MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS

Model Number 2217-50-041

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

On (b)(6)2022 dr was inserting an acetabular shell into a patient and while doing so, the threaded part of the impaction handle that threads into the shell came loose and when the handle was unthreaded, this threaded part stayed in the shell.All pieces (2) of the handle were retrieved and surgery was completed without any other complications.There was a five minute surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).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.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).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 :visual analysis of the returned sample exhibited 221750041/pinn straight cup impactor with a missing cup impactor threaded tip.Welding trace could be observed all around de the edge of the shaft's end where tip was fixated.Based on observations of the device condition it is not unreasonable to conclude that progressive loosening of the welding union was present through the operational time.The separated insert was not returned for examination.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 :a date code was provided, which indicates that the device was manufactured on 2010.A manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.Corrected: h3 and h4.

• Brand Name: PINN STRAIGHT CUP IMPACTOR
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15111686
• MDR Text Key: 302345589
• Report Number: 1818910-2022-14153
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2022

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: 2217-50-041
• Device Catalogue Number: 221750041
• Device Lot Number: J0510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 07/29/2022; 07/29/2022; 09/02/2022
• Supplement Dates FDA Received: 08/03/2022; 08/03/2022; 09/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1