MAUDE Adverse Event Report: DEPUY IRELAND LOCKING SCREW 30; SHOULDER IMPLANT - LOCKING SCREW

Catalog Number	550310030
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 while inserting a small modular baseplate and locking screw inferiorly, the locking screw did not catch in the baseplate; it sunk through.Another locking screw was tried, and it did the same thing.The baseplate was left in place along with the second locking screw.Two peripheral screws were also placed; they locked in with no issues.Doe: (b)(6) 2025.Affected side: right shoulder.
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.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 the surgeon inserted a small modular baseplate and placed a 30 locking screw inferiorly.The locking screw did not catch in the baseplate it sunk through.He pulled the 30 out and placed another 30 locking screw and it did the same thing.Surgeon didn't want to remove the baseplate because the footprint was already created so he left it in place along with the second 30 locking screw.He placed the other two peripheral screws and they locked in just fine.User was not sure if it is an issue with the lot# for the screws or if one of the holes in the baseplate was incorrect, so he included both baseplate and both locking screws on this mdr.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the locking screw 30 was found slightly cross-threaded from the driving recess and upper threads.Additionally, what appears to be organic material was found in the same area.No other damage was observed.A manufacturing record evaluation was performed for the finished device product code: 550310030 lot number: 229909, and no non-conformances or manufacturing irregularities were identified.As per inhance¿ surgical technique "peripheral screws must be fully seated within the baseplate manually using the star driver 20 and the driver handle".It is worth noting that "locking screws should not be used under power to fully seat the screw head as this can result in the screw head passing through the baseplate peripheral hole".The observed damaged condition suggests that the locking screw was exposed to excessive forces ultimately contributing to the screw passing through the baseplate as reported.Since the mating baseplate was not returned, no observations could be made to assess whether it may have contributed to the reported event.Without additional information, it is not possible to determine a root cause.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the locking screw 30 would have contributed to the complained issue.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 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 - a manufacturing record evaluation was performed for the finished device product code: 550310030 lot number: 229909, and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: added: d10 (concomitant).Corrected: h3.

• Brand Name: LOCKING SCREW 30
• Common Device Name: SHOULDER IMPLANT - LOCKING SCREW
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22108327
• Report Number: 1818910-2025-08711
• Device Sequence Number: 7276235
• Product Code: HSD
• UDI-Device Identifier: 10603295546597
• UDI-Public: (01)10603295546597(17)291130(10)229909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 550310030
• Device Lot Number: 229909
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 10/07/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/10/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKING SCREW 30; MODULAR UNITI BASEPLATE S 24
• Patient Sex: Male