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

Model Number	96-6312
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Sp2 tibial guide requires replacement, screws are worn out and so the system won¿t work properly.
Additional 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
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11592608
• Report Number: 1818910-2021-06539
• Device Sequence Number: 11836317
• Product Code: HWT
• UDI-Device Identifier: 10603295247784
• UDI-Public: 10603295247784
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 96-6312
• Device Catalogue Number: 966312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1