MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 REMOVABLE HANDLES PKG 2EA; KNEE INSTRUMENT : HANDLES

Model Number	96-6147
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device the locking mechanism broken resulting in the inability to retain a mating device.The damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Event or Problem Description
It was reported that ball bearings no longer work on the handle and it needs to be replaced.No surgical delay.

• Brand Name: SP2 REMOVABLE HANDLES PKG 2EA
• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11149139
• Report Number: 1818910-2021-00839
• Device Sequence Number: 10968709
• Product Code: LXH
• UDI-Device Identifier: 10603295247029
• UDI-Public: 10603295247029
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: GM0208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 96-6147
• Device Catalogue Number: 966147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1