12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Report

Report Number: 1719045-2015-10508
Event Type: Injury
Date Received: August 12, 2015
Date of Event: July 21, 2015
Report Date: July 24, 2015
Manufacturer: SYNTHES SELZACH
Product Code: HTO
PMA / PMN Number: PK111437
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER PROVIDED. THE LOT NUMBER CORRESPONDS TO THE LOT NUMBER DELEGATED UPON STERILIZATION OF THE SUBJECT DEVICE LOT AND, THEREFORE, ONLY THE RECORDS PERTAINING TO THE STERILIZATION OF THE DEVICE, THE SYNTHES LOCATION, AND THE NEW MANUFACTURING AND EXPIRATION DATES ASSOCIATED WITH THE STERILIZATION COULD BE OBTAINED. SINCE THE COMPLAINT CONDITION WAS NOT ASSESSED AS BEING RELATED TO STERILIZATION, AN ATTEMPT WAS MADE TO OBTAIN MANUFACTURING RECORDS RELATING TO THE NON-STERILE DEVICE (PART 352.250, LOT 474817); HOWEVER, THE LOT NUMBER PROVIDED COULD NOT BE CROSS-REFERENCED AT THIS TIME TO THE US SYNTHES MANUFACTURER. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

AN ADDITIONAL DEVICE HISTORY RECORD REVIEW: THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. VENDOR OF THE CORRESPONDING NON-STERILE PART 352.250, LOT 7802653 IS SYNTHES (B)(4), INC. PART: 352.252, LOT: 7474817 (NON-STERILE) - STAR/HEXDRIVE SCREWDRIVER T25 3.5 MM HEX/SELF- RETAINING. NON-STERILE LOT WAS RELEASE TO THE WAREHOUSE ON 29OCTOBER2013. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

(B)(4). HOSPITAL CONTACT NUMBER: (B)(6). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

PATIENT INITIALS: (B)(6). ADDITIONAL PRODUCT CODE: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WAS FINALIZING THE REAMING OF THE MEDULLARY CANAL OF THE FEMUR OF THE PATIENT WITH THE REAMER, IRRIGATOR, ASPIRATOR (RIA) SYSTEM WHEN IT WAS NOTED IN THE X-RAYS THAT THE REAMER HEAD IS DISASSEMBLED OF THE DRIVE SHAFT. WHEN THE RIA SYSTEM WAS REMOVED FROM THE PATIENT'S BONE AND IT WAS NOTED THAT THE TIP OF THE DRIVE SHAFT WAS BROKEN, ALSO THE REAMER HEAD FINS BROKE; IT WAS LEFT WITHIN THE MEDULLARY CANAL OF THE FEMUR OF THE PATIENT. THE PROCEDURE WAS PROLONGED BY TWENTY-FIVE (25) MINUTES. IT WAS REPORTED A RE-OPERATION IS NECESSARY FOR THE PATHOLOGY OF THE PATIENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
528838	12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR	REAMER	HTO	SYNTHES SELZACH		9414474

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention