MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS TIB SPACER ASSY 12.5MM; KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS

Catalog Number	226731000
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
12.5 mm shim isn't attaching to the spacer handle.It fell off during the case and a new tray needed to be opened.It was tested on a different handle and continued to be loose and fall off.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 5 mins.Action taken when event occurred? a new instrument set was opened.Was procedure successfully completed? yes.Were fragments generated? no.Patient status/ outcome / consequences? no.
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.H10 additional narrative: product complaint (b)(4).Investigation summary : the device was reviewed by depuy engineering melbourne in a-2830102 which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.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.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.

• Brand Name: LCS TIB SPACER ASSY 12.5MM
• Common Device Name: KNEE INSTRUMENT : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8869659
• Report Number: 1818910-2019-100326
• Device Sequence Number: 18888858
• Product Code: HWT
• UDI-Device Identifier: 10603295108801
• UDI-Public: 10603295108801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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 Catalogue Number: 226731000
• Device Lot Number: MX0507
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1