MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HANDLE SLEEVE DRIVER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 535801

Device Problems Connection Problem (2900); Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)

Patient Problem Not Applicable (3189)

Event Date 09/19/2019

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

It was reported that the size 16 sleeve introducer and handle no longer stay attached.Doctor indicates both parts were worn and needed replacing.Please send replacement parts to (b)(4) office.There was a 30 seconds surgical delay.

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 device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.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.

• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9175645
• MDR Text Key: 163119066
• Report Number: 1818910-2019-109171
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295172710
• UDI-Public: 10603295172710
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 535801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR