MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 CONCAVE IMPACTOR TIP; SHOULDER INSTRUMENT - IMPACTOR TIP

Catalog Number 620510103

Device Problems Naturally Worn (2988); Scratched Material (3020)

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

Event Date 01/01/2023

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 concave impactor tip has a gash that extends into the threads and they were stripped.

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: according to the information received, "while impacting the glenosphere onto the baseplate the concave impaction tip broke and came off of the impactor handle." the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that the concave impactor tip had broken impactor tip near and around the threaded region of the impactor where the impactor handle assemble the broken fragment was not returned for examination.Also the rest of the threaded present signs of stripped and scratched around the device.The reported condition can be confirmed.The radel concave impactor tip fractured through the threads at interface of the distal flat where the mating metal impaction handle threads into.The location of the fracture in combination with observed thread damage and crack propagation in the threaded region of the impactor tip suggests brittle overload from uneven distribution of load during impaction.On the basis of these observations, the potential cause is traced to unintended use error due to uneven force applied during impaction.No material or manufacturing defects were observed that could have contributed to the observed fracture.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the concave impactor tip would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 manufacturing records evaluation (mre) was not performed.

Event Description

Additional information received indicates that there was a gash in the device near the threads.The gash extended into the threads and they were stripped.It did not break into two or more pieces and was not used in surgery.

• Brand Name: CONCAVE IMPACTOR TIP
• Type of Device: SHOULDER INSTRUMENT - IMPACTOR TIP
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 18007770
• MDR Text Key: 326931501
• Report Number: 1818910-2023-21724
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295539407
• UDI-Public: 10603295539407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 620510103
• Device Lot Number: 173396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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