MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REV FEM/TIB/SLEEVE CLAMP; KNEE INSTRUMENT : CLAMPS

Catalog Number 217863134

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

It was reported that during inspection the product was found not to be working.Locks up femoral/tibial wrench.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : examination of the returned device confirmed the reported locked condition.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: REV FEM/TIB/SLEEVE CLAMP
• Type of Device: KNEE INSTRUMENT : CLAMPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 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: 7881803
• MDR Text Key: 120461689
• Report Number: 1818910-2018-69537
• Device Sequence Number: 1
• Product Code: HXD
• UDI-Device Identifier: 10603295096238
• UDI-Public: 10603295096238
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217863134
• Device Lot Number: TBJNP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1