MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT SZ2/3 TAPERED REAMER; HIP INSTRUMENTS : REAMERS

Catalog Number 257002100

Device Problems Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

Patient Problem Not Applicable (3189)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Examination of the returned instrument found the reamer to be damaged.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.

Event Description

Surgeon using our summit reamers and that the 2/3 summit reamer became stuck on the t-handle.After about a 1 minute delay, the reamer was removed and the nurse tested to t-handle on other reamers to determine whether it was the reamer or the t-handle that was causing the issue.The t-handle worked fine on the other reamers and we found that the 2/3 reamer continued to get stuck when testing it after the surgery.There was no patient consequence and there was a 1-minute delay in surgery.Lot # is j1110.Was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> 1, was procedure successfully completed? --> yes, were fragments generated? --> no, patient status/ outcome / consequences --> no.

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 instrument found the reamer to be damaged.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.Based on the investigation, the need for corrective action is not indicated.Continue to monitor complaints under post market surveillance sep-419.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.

Manufacturer Narrative

Added lot number and and corrected date in report.

• Brand Name: SUMMIT SZ2/3 TAPERED REAMER
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8597201
• MDR Text Key: 144824478
• Report Number: 1818910-2019-93073
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295143000
• UDI-Public: 10603295143000
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 257002100
• Device Lot Number: J1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1