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

Catalog Number	620510104
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional 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 the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that glenoid impactor tip had damaged threads and needed to be replaced.There was no time delay for the surgery.There was no patient consequence.
Additional 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.H11 additional narrative: added: d9, g1 (manufacturing site name).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that glenoid impactor tip had damaged threads and needs to be replaced.There was no time delay for the surgery.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the convex impactor tip was stripped from the threaded region.The observed condition in the threaded region of the impactor tip suggests brittle overload from uneven distribution of load during impaction.Based on the observations, the potential cause can be attributed to unintended use error due to uneven force applied during impaction.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the convex impactor tip would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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 in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information was received and confirmed that the device was cross-threaded.

• Brand Name: CONVEX IMPACTOR TIP
• Common Device Name: 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21137216
• Report Number: 1818910-2025-00659
• Device Sequence Number: 6825382
• Product Code: HWA
• UDI-Device Identifier: 10603295539414
• UDI-Public: (01)10603295539414(10)200500
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 620510104
• Device Lot Number: 200500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 02/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/16/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown