MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG ANKLE CLAMP; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number	9505-01-229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that broken items were found in wash.Parts are being returned.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device was unable to confirm the reported breakage.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: HP EM TIBIAL JIG ANKLE CLAMP
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11139380
• Report Number: 1818910-2021-00657
• Device Sequence Number: 19757585
• Product Code: HTZ
• UDI-Device Identifier: 10603295225348
• UDI-Public: 10603295225348
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 12/16/2020

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: 9505-01-229
• Device Catalogue Number: 950501229
• Device Lot Number: PM0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 01/29/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/12/2021; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1