MITEK EXPRESSEW III NEEDLE

Report

Report Number: 1221934-2014-00442
Event Type: Injury
Date Received: October 10, 2014
Date of Event: October 9, 2014
Report Date: October 9, 2014
Manufacturer: DEPUY MITEK
Product Code: LXH
PMA / PMN Number: EXEMPT
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT DEVICE IS NOT BEING RETURNED AND THEREFORE NOT AVAILABLE FOR A PHYSICAL EVALUATION. FROM PAST INVESTIGATIONS OF SIMILAR FAILURE MODES, IT HAS BEEN DETERMINED THAT REPEATEDLY PASSING THE NEEDLE THROUGH EXCESS TISSUE CAUSES THE NEEDLE TO FATIGUE AND BREAK. EIII NEEDLES HAVE BEEN DESIGNED TO PASS 15 TIMES THROUGH TISSUE AND ANY USAGE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED IF AFOREMENTIONED FACTORS CONTRIBUTED TO THE EVENT. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH AN UNRELATED INCIDENT WITH NO LINK TO THIS COMPLAINT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED 1 SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE COMPLAINT RATE HAS BEEN REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED LEVELS. BASED ON THE COMPLAINT HISTORY, NO FURTHER CORRECTIVE ACTION IS WARRANTED AT THIS TIME. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION THAT IS PERTINENT TO THIS ISSUE. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

Additional Manufacturer Narrative · 1

THIS IS A FOLLOW UP REPORT TO DOCUMENT DEVICE RETURN. A FINAL REPORT WILL BE FILED ONCE THE DEVICE HAS BEEN INVESTIGATED.

Additional Manufacturer Narrative · 1

THE COMPLAINT DEVICE HAS BEEN RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THAT THE TIP OF THE NEEDLE IS BROKEN, CONFIRMING THIS COMPLAINT. FROM PAST INVESTIGATIONS OF SIMILAR FAILURE MODES, IT HAS BEEN DETERMINED THAT REPEATEDLY PASSING THE NEEDLE THROUGH EXCESS TISSUE CAUSES THE NEEDLE TO FATIGUE AND BREAK. EII NEEDLES HAVE BEEN DESIGNED TO PASS 15 TIMES THROUGH TISSUE AND ANY USAGE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE. AT THIS POINT, IT CANNOT BE DETERMINED IS ANY OTHER FACTORS CONTRIBUTED TO THIS EVENT. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH ONE UNRELATED INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE COMPLAINT RATE HAS BEEN REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED LEVELS. BASED ON THE COMPLAINT HISTORY, NO FURTHER CORRECTIVE ACTION IS WARRANTED AT THIS TIME. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION THAT IS PERTINENT TO THIS ISSUE. DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

Additional Manufacturer Narrative · 1

ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY SYNTHES MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY SYNTHES MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. IN TRANSIT.

Description of Event or Problem · 1

NEEDLE BREAKAGE. BROKEN NEEDLE ON A NON THICK CAP AND NORMAL USE .THE FIRST NEEDLE (A402026) BROKE AT THE 4TH PASSAGE AND WAS RECOVERED AND THE SECOND (A402024) BROKE AT THE 8TH PASSAGE NOT FOUND, RX VERIFICATION UNDERWAY. NO CONSEQUENCES TO THE PATIENT- ANOTHER LIKE DEVICE WAS USED. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON (B)(6) 2014; THE PIECE OF THE SECOND NEEDLE REMAINS UNDER THE SKIN SEE ASSOCIATED MEDWATCH # .1221934-2014-00441.

Description of Event or Problem · 1

NEEDLE BREAKAGE. BROKEN NEEDLE ON A NON THICK CAP AND NORMAL USE .THE FIRST NEEDLE ((B)(4)) BROKE AT THE 4TH PASSAGE AND WAS RECOVERED AND THE SECOND ((B)(4)) BROKE AT THE 8TH PASSAGE NOT FOUND, RX VERIFICATION UNDERWAY. NO CONSEQUENCES TO THE PATIENT- ANOTHER LIKE DEVICE WAS USED. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 10-10-14; THE PIECE OF THE SECOND NEEDLE REMAINS UNDER THE SKIN. SEE ASSOCIATED MEDWATCH # 1221934-2014-00441.

Description of Event or Problem · 1

NEEDLE BREAKAGE. BROKEN NEEDLE ON A NON THICK CAP AND NORMAL USE .THE FIRST NEEDLE ((B)(4)) BROKE AT THE 4TH PASSAGE AND WAS RECOVERED AND THE SECOND ((B)(4)) BROKE AT THE 8TH PASSAGE NOT FOUND, RX VERIFICATION UNDERWAY. NO CONSEQUENCES TO THE PATIENT- ANOTHER LIKE DEVICE WAS USED. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 10-10-14; THE PIECE OF THE SECOND NEEDLE REMAINS UNDER THE SKIN SEE ASSOCIATED MEDWATCH # 1221934-2014-00441.

Description of Event or Problem · 1

NEEDLE BREAKAGE. BROKEN NEEDLE ON A NON THICK CAP AND NORMAL USE .THE FIRST NEEDLE (A402026) BROKE AT THE 4TH PASSAGE AND WAS RECOVERED AND THE SECOND (A402024) BROKE AT THE 8TH PASSAGE NOT FOUND, RX VERIFICATION UNDERWAY. NO CONSEQUENCES TO THE PATIENT- ANOTHER LIKE DEVICE WAS USED. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 10-10-14; THE PIECE OF THE SECOND NEEDLE REMAINS UNDER THE SKIN. SEE ASSOCIATED MEDWATCH # .1221934-2014-00441.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
640565	MITEK EXPRESSEW III NEEDLE	ARTHROSCOPIC SUTURE PASSER NEEDLE	LXH	DEPUY MITEK	NA	A402024

Patients

Seq	Age	Sex	Outcome	Treatment
1