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

Catalog Number 950502808

Device Problems Crack (1135); Peeled/Delaminated (1454); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> 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.

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 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
• Type of Device: KNEE INSTRUMENT : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 9506258
• MDR Text Key: 184389192
• Report Number: 1818910-2019-124501
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10603295229360
• UDI-Public: 10603295229360
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1