MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG HP REV DISTAL SPACER 8MM; KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS

Catalog Number	201103022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned product revealed breakage.Depuy 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.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 instrument piece was broken and removed from the field and not used on the patient.No surgical delay.All pieces were retrieved.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: examination of the returned product revealed breakage.Depuy 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.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 REV DISTAL SPACER 8MM
• Common Device Name: KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7361099
• Report Number: 1818910-2018-55803
• Device Sequence Number: 16169754
• Product Code: HWT
• UDI-Device Identifier: 10603295081432
• UDI-Public: 10603295081432
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: 201103022
• Device Lot Number: SO2021516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 69