MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR HEAD BALL REMOVER; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2125-00-600

Device Problems Dull, Blunt (2407); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

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 calcar planers will not cut bone (dull).Srom adapters broke where reamers attach.Modular head remover will not mate with srom adapter or hudson.No surgical delay.

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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Visual exam found the hudson end is worn.Depuy-synthes 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.

• Brand Name: MODULAR HEAD BALL REMOVER
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9786438
• MDR Text Key: 181978116
• Report Number: 1818910-2020-06797
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295087878
• UDI-Public: 10603295087878
• 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,Followup,Followup
• Report Date: 02/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 2125-00-600
• Device Catalogue Number: 212500600
• Device Lot Number: SO2037308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 04/09/2020; 07/27/2020; 08/07/2020
• Supplement Dates FDA Received: 04/14/2020; 07/29/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR