MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP FIXED REF POST ROT GDE 3DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	9505-01-265
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
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.
Event or Problem Description
During case the femoral sizer and the femoral posterior referencing femoral rotation guides were not going together easily.Then once we got it on it was extremely difficult to take off.Had to use a hohman to remove the femoral rotation guide.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned devices confirmed the reported event.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: the current complaint sample was manufactured prior to the supplier corrective actions.Added: d4 (lot #), h4 corrected: h3 and h6 (clinical code).

• Brand Name: HP FIXED REF POST ROT GDE 3DEG
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10741400
• Report Number: 1818910-2020-23385
• Device Sequence Number: 11514741
• Product Code: HWT
• UDI-Device Identifier: 10603295225683
• UDI-Public: 10603295225683
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/12/2020

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: 9505-01-265
• Device Catalogue Number: 950501265
• Device Lot Number: PG0209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1