FDA Adverse Event Injury Summary report: N

SIG FEM ADPT TORQUE WRENCH

MDR report key: 5039355 · Received August 28, 2015

Report

Report Number: 1818910-2015-29266
Event Type: Injury
Date Received: August 28, 2015
Date of Event: August 10, 2015
Report Date: August 10, 2015
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EXAMINATION OF THE SIG FEM ADPT TORQUE WRENCH CONFIRMED THE BLACK PROTECTIVE CAP IS BROKEN. CAPA (B)(4) WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF (B)(4). NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)

Description of Event or Problem · 1

FEMORAL ADAPTOR TORQUE WRENCH AND TIBIAL WRENCH DID NOT WORK PROPERLY DURING IMPLANT ASSEMBLY. BOTH ARE INTACT BUT ARE NOT FUNCTIONING PROPERLY. *UPDATE AUGUST 27, 2015 UPON EVALUATION OF 961673 SIG FEM ADPT TORQUE WRENCH, THE BLACK PROTECTIVE CAP WAS FOUND TO BE BROKEN. (B)(4)

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
572394	SIG FEM ADPT TORQUE WRENCH	KNEE INSTRUMENT/TRIAL	LXH	DEPUY ORTHOPAEDICS, INC.		A1208

Patients

Seq	Age	Sex	Outcome	Treatment
1