MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2EXTRAMED PROX TIB ALIGN DEV; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number	96-6311
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2020
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.Investigation summary: the device associated with the reported event was not returned for evaluation.Visual examination of the provided photographs confirmed the confirmed the knob component of the retractable plunger mechanism was broken and separated from the device.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
The procedure was carried out without complications, but after washing the instruments, the piece was damaged, photos of the piece are attached.

• Brand Name: SP2EXTRAMED PROX TIB ALIGN DEV
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11618773
• Report Number: 1818910-2021-07108
• Device Sequence Number: 3279652
• Product Code: HWT
• UDI-Device Identifier: 10603295247777
• UDI-Public: 10603295247777
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 04/05/2021

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: 96-6311
• Device Catalogue Number: 966311
• Device Lot Number: TBNCW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1