FDA Adverse Event Injury Summary report: N

DISSECTOR, 4.0MM X 13CM

MDR report key: 1860811 · Received October 7, 2010

Report

Report Number: 1220246-2010-00185
Event Type: Injury
Date Received: October 7, 2010
Date of Event: August 4, 2010
Report Date: September 15, 2010
Manufacturer: ARTHREX, INC.
Product Code: GFA
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. THE EVALUATION REVEALED THAT THE EVENT IS CAUSED BY THE OBSERVED CONDITION WHICH SHOWED THAT THE TIP BROKE OFF THE OUTER SHAFT AND ALSO BOTH INNER AND OUTER SHAFTS WERE SLIGHTLY BENT. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS APPLYING EXCESSIVE BENDING/LEVERAGING FORCE ON THE DEVICE DURING USE. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TIP OF THE SHEATH SNAPPED OFF TRYING TO REACH THE POSTERIOR HORN OF THE MEDIAL MENISCUS. HAD TO MAKE THE MEDIAL INCISION LARGER IN ORDER TO REMOVE BROKEN PIECE. KNEE MENISECTOMY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DISSECTOR, 4.0MM X 13CM	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	GFA	ARTHREX, INC.		H355829

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR		Other