MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CALCAR PLANER-SMALL; HIP INSTRUMENTS : REAMERS

Catalog Number 257004100

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

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 Description

Complaint description: the calcar planers will not cut through bone.

Manufacturer Narrative

Product complaint(b)(4).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.H10 additional narrative: investigation summary : examination of the returned instrument confirmed the reported observation.The root cause is attributed to heavy usage/wear out.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.Territory 230 reported the calcar planer will not cut through bone.Examination of the returned instrument confirmed the complaint; planer is dull.Visual examination also found the date (b)(6) on the shaft indicating the instrument was worked on in (b)(6) 2016.A search of the complaint database found similar reports for this failure and the root cause was attributed to heavy usage wear out.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under sep 419 post market surveillance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT CALCAR PLANER-SMALL
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8898413
• MDR Text Key: 154624104
• Report Number: 1818910-2019-101272
• Device Sequence Number: 1
• Product Code: LYS
• UDI-Device Identifier: 10603295143178
• UDI-Public: 10603295143178
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 257004100
• Device Lot Number: HW77404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR