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

Catalog Number 221750041

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

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the impaction end of the handle is loose.Where / when did the event occur? intra-op.Was surgery time extended as a direct result of incident? no.What action was taken/required to manage the problem during the procedure? with same like product.Was a patient involved? yes.Is litigation indicated or pending? no.

Event Description

Additional information was received and states that one part of the instrument was loose.

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 that 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: hammerplate is loose.Where / when did the event occur? intra-op.Was surgery time extended as a direct result of incident? no.What action was taken/required to manage the problem during the procedure? with same like product.Was a patient involved? yes.Is litigation indicated or pending? no.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed there were no product problems with pinn straight cup impactor.The allegation of broken was not confirmed.The investigation was not able to confirm the complaint.The overall complaint was not confirmed as the pinn straight cup impactor was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = hammerplate is loose.Where / when did the event occur? intra-op.Was surgery time extended as a direct result of incident? no.What action was taken/required to manage the problem during the procedure? with same like product.Was a patient involved? yes.Is litigation indicated or pending? no.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed there were no product problems with pinn straight cup impactor.The allegation of broken was not confirmed.The investigation was not able to confirm the complaint.The overall complaint was not confirmed as the pinn straight cup impactor was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.

• 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: 17950674
• MDR Text Key: 325861283
• Report Number: 1818910-2023-21194
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221750041
• Device Lot Number: SO2055048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2022
• 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