MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL LOCATING DEVICE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number 96-6110

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/01/2020

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

Pin fell out.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10620229
• MDR Text Key: 209594362
• Report Number: 1818910-2020-21460
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295246831
• UDI-Public: 10603295246831
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-6110
• Device Catalogue Number: 966110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1