MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SIG HP FEMORAL TRIALS CASE; KNEE INSTRUMENT : INSTRUMENT CASES

Model Number	9505-02-804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterile processing noticed a couple of sigma trays were starting to chip, so they want to get them replaced for sanitary reasons.
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 this report was returned.Physical examination of the product found that the case coating was peeling off/delaminating.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: SIG HP FEMORAL TRIALS CASE
• Common Device Name: KNEE INSTRUMENT : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13759673
• Report Number: 1818910-2022-04616
• Device Sequence Number: 20319045
• Product Code: FSM
• UDI-Device Identifier: 10603295229322
• UDI-Public: 10603295229322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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: 9505-02-804
• Device Catalogue Number: 950502804
• Device Lot Number: E68R54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown