MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT SZ6/7 TAPERED REAMER; HIP INSTRUMENTS : REAMERS

Catalog Number 257002300

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem Not Applicable (3189)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.

Event Description

It was reported that during a total hip arthroplasty, the size 6/7 summit tapered reamer was damaged at the top not allowing the reamer to engage with the hudson adapter.There was a 2 minutes surgical delay.It was indicated by the sales rep that there were no pieces broke off during surgery.It seems as though it was stripped at the top where it engaged with the hudson adapter.There were no deficiencies with the hudson adapter on the drill as the other reamers worked.

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.Corrected: device evaluated by mfr.Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.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: SUMMIT SZ6/7 TAPERED REAMER
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8440887
• MDR Text Key: 139470241
• Report Number: 1818910-2019-88057
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295143024
• UDI-Public: 10603295143024
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 257002300
• Device Lot Number: SO2016943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1