MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS FNSH GDE SM+ .060 IN SLOTS; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	228752000
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the investigation identified the returned device was damaged/worn.The noted damage/wear is consistent with device wear out through heavy use and servicing and the investigation did not establish a need for corrective action.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 will be filed as appropriate.
Event or Problem Description
It was reported that the femoral trial was loose than usual after cutting bone with the a/p resection guide sm+ (p/n: (b)(4)) during the tka surgery on (b)(6) 2019.The surgery was completed without a surgical delay and there was no adverse consequence to the patient.We obtained the investigation request whether size of the a/p resection guide in question was defective originally or not.No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).The investigation identified the returned device was damaged/worn.The noted damage/wear is consistent with device wear out through heavy use and servicing and the investigation did not establish a need for corrective action.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) 228752000 lcs fnsh gde sm+.060 in slots.The date code aa0793b marked on the device indicates this instrument was manufactured in july 1993.Examination of the returned cutting guide identified heavy deformation, scratches, and marring due to heavy usage and servicing during its time in the field.Due to the age and damage observed on the cutting guide, the root cause is attributed to device wear out through heavy use and servicing in the field over an extended period.Based on the root cause determination of device wear out, no broader investigation or corrective action was found to be necessary.Monitor complaints through sep-419.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 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: the investigation identified the returned device was damaged/worn.The noted damage/wear is consistent with device wear out through heavy use and servicing and the investigation did not establish a need for corrective action.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 will be filed as appropriate.

• Brand Name: LCS FNSH GDE SM+ .060 IN SLOTS
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9192864
• Report Number: 1818910-2019-109965
• Device Sequence Number: 16746511
• Product Code: HWT
• UDI-Device Identifier: 10603295110231
• UDI-Public: 10603295110231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2019

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: 228752000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 12/16/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/05/2019; 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1