MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG FEM ADPT TORQUE WRENCH; KNEE INSTRUMENT : TORQUE DEVICES

Catalog Number 961673

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The adapter torque wrench instrument in the images 1 & 2 attached (961673 lot so2008136), which came with module uksig01s orthokit booking lk10748568, is faulty and did not fully seat and engage with the definitive adapter implant.This delayed surgery today on (b)(6) 2018 by about 10 mins.It was lucky that i had a spare on module 1718, (image 3) which did properly engage the implant.The problem is clearly with the black plastic section on the distal end.The torque wrench which worked correctly, does not have this but instead has a white plastic protector on the inside of the hex fitting.

Manufacturer Narrative

Product complaint # : (b)(4).Examination of the returned instrument and photographs confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG FEM ADPT TORQUE WRENCH
• Type of Device: KNEE INSTRUMENT : TORQUE DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7655008
• MDR Text Key: 112891857
• Report Number: 1818910-2018-63643
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295239789
• UDI-Public: 10603295239789
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 961673
• Device Lot Number: SO2008136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1