MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG HP FB STB INSERT TRIAL CSE; KNEE INSTRUMENT : INSTRUMENT CASES

Catalog Number	950502814
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned device revealed the brackets are delaminating.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint sample consisted of (1) 950502814 sig hp fb stb insert trial cse, lot code dv3bs4.Examination of the submitted sigma hp instruments case revealed the coating on the brackets are delaminating.The product lot code indicates a manufacture date of 2009.A search of the complaint database found additional reports of bracket delamination for sigma hp instrument cases against the lot code.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 a capa.Complaints trends will be monitored by post market surveillance through sep-(b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
The instruments were reported for unknown reason.During in-house engineering evaluation, it was determined that the coating on the brackets were delaminating.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint # (b)(4).Investigation summary examination of the returned device revealed the brackets are delaminating.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: SIG HP FB STB INSERT TRIAL CSE
• Common Device Name: KNEE INSTRUMENT : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8483397
• Report Number: 1818910-2019-89775
• Device Sequence Number: 2006379
• Product Code: FSM
• UDI-Device Identifier: 10603295229421
• UDI-Public: 10603295229421
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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 Expiration Date: 05/01/2014
• Device Catalogue Number: 950502814
• Device Lot Number: DV3BS4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR