MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 P.F.C.* PRESS-FIT ROD WRENCH; KNEE INSTRUMENT/TRIAL

Catalog Number 865189

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

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 the wrenching mechanism is bound and did not tighten to the stem.

Manufacturer Narrative

Additional narrative: examination of the returned device confirmed the reported event.Depuy considers the investigation closed at this time.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.

• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6834269
• MDR Text Key: 84125177
• Report Number: 1818910-2017-23820
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295216759
• UDI-Public: 10603295216759
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 865189
• Device Lot Number: GM0904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2004
• 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
• Patient Age: 66 YR