MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI FEMORAL TIP GOUGE; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	202457000
Medical Device Problem Codes	Break (1069); Corroded (1131); Pitted (1460)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
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
It was reported that the surgeon was using the gauge on the anterior distal femur to remove bone.On the first impact the gauge was broke.All pieces were recovered.No surgical delay.
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 confirms the reported the device breakage.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI FEMORAL TIP GOUGE
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8748854
• Report Number: 1818910-2019-97239
• Device Sequence Number: 2155266
• Product Code: GDH
• UDI-Device Identifier: 10603295083375
• UDI-Public: 10603295083375
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2019

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: 202457000
• Device Lot Number: PG0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/19/2019; 09/10/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/09/2019; 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1