MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2EXTRMD PROX ALIGN DEV SPKE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number 96-6312

Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

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

Surgeon spiked tibial alignment guide ¿ one of the spikes was bent upon impaction into the tibia ¿ item is over 8 years old ¿ wear and tear.No impact to surgery.No delay to surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: SP2EXTRMD PROX ALIGN DEV SPKE
• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12204125
• MDR Text Key: 262702285
• Report Number: 1818910-2021-15622
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295247784
• UDI-Public: 10603295247784
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-6312
• Device Catalogue Number: 966312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1