MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG HP PATELLA & INSERTION CSE; KNEE INSTRUMENT : INSTRUMENT CASES

Catalog Number	950502808
Medical Device Problem Codes	Crack (1135); Peeled/Delaminated (1454); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned device confirmed the reported damage.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported damage.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint sample consisted of (1) 950502808 sig hp patella & insertion case.Examination of the submitted instrument case confirmed the brackets that secure the surgical instruments in the case are delaminating.The overall condition of the instrument case indicates heavy usage.A search of the complaint database found additional reports of bracket delamination for sigma hp instrument cases.Previous investigation did not conclusively determine the root cause, although it is the supplier manufacturing process related.Details of this issue have been documented through pra / hhe (b)(4) and capa (b)(4).The investigation findings did not indicate that a broader investigation or corrective action was necessary.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 the trays are worn and old.Need to be replaced.Plastic instrument holders in trays are cracked.

• Brand Name: SIG HP PATELLA & INSERTION CSE
• Common Device Name: KNEE INSTRUMENT : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9506258
• Report Number: 1818910-2019-124501
• Device Sequence Number: 2086046
• Product Code: FSM
• UDI-Device Identifier: 10603295229360
• UDI-Public: 10603295229360
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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 Catalogue Number: 950502808
• Device Lot Number: C71DB4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1