MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 STAR DRIVER 30; SCREWDRIVERS

Catalog Number	620510102
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional 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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
During an inhance shoulder procedure: multiple inserter rods, stripped, broken.Originally replaced by customer.Repeated issue with same instruments.There was a surgical delay of thirty minutes.
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: corrected: h6 (updated pe code from functional: jammed/seized to device interaction (2+ devices) unable to disassemble).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).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 hat 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: b5, h6 (medical device problem code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: for context: yes, 5 events of the baseplate inserter rod: not accepting glenosphere inserter tip (would not screw on to the rod).Stardrive 30 stripped/bent/fused x3 occasions.(which connects to glenosphere inserter tip on other end.5x 650011102, 3x 620510102, 3x 650011104.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿multiple inserter rods, stripped, broken.Originally replaced by customer.Repeated issue with same instruments.Account unwilling to continue to purchase and replace.Inserter rod strips: #650011102.Glenosphere inserter bolt strips rod inserter, or breaks off screwdriver (back up instrument) #650011104.T30 driver twists and breaks.Strips/welds to glenosphere bolt #620510102¿ additionally, "for context: yes, 5 events of the baseplate inserter rod: not accepting glenosphere inserter tip (would not screw on to the rod) stardrive 30 stripped/bent/fused x3 occasions.(which connects to glenosphere inserter tip on other end".The product was not returned to depuy synthes, however photos were provided for review.See attachments 79388565561__601502fb-5e95-4362-ba3a-cd667489272f, 79388565561__601502fb-5e95-4362-ba3a-cd667489272f.Jpeg(1), (b)(4) device photo ad 17 mar 2026 (2) and (b)(4) device photo ad 17 mar 2026.Review of the photographic evidence revealed just two star driver 30.No evidence of a third device was observed in the provided pictures.The two devices were documented under related complaints (b)(4).As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of a third device.Based on the investigation findings, 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 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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: STAR DRIVER 30
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24579443
• Report Number: 1818910-2026-04672
• Device Sequence Number: 10474834
• Product Code: HWR
• UDI-Device Identifier: 10603295539391
• UDI-Public: (01)10603295539391
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 620510102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 04/27/2026; 05/25/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/10/2026; 04/29/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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