MAUDE Adverse Event Report: Limacorporate S.p.A. BONE SCREWS; Cortical Bone Screw - Flattened Head Dia. 5 mm L. 30 mm

Model Number	8432.15.030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on 2nd september 2026 due to breakage of screw.On x-ray taken on 31st august 2026 revealed that a screw had broken.During the revision procedure, all implant components were removed from the patient's body.No information is available regarding any traumatic event that may have contributed to the occurrence.Previous surgery was performed on (b)(6)2025.Hereby the devices implanted on previous surgery ((b)(6) 2025).During the revision surgery, all devices were removed except for the stem, and no new implants were inserted.There were three screws implanted and we do not know which one was broken: · cortic.Bone screw d.5 l.26 mm (product code: 8432.15.026 - lot: 2108014).· cortic.Bone screw d.5 l.30 mm (product code: 8432.15.030 - lot: 2408956).· cortic.Bone screw d.5 l.30 mm (product code: 8432.15.030 - lot: 2511464) · smr reverse humeral body (product code: 1352.20.010 - lot: 2505566).· smr reverse liner + 6 mm (product code: 1360.50.020 - lot: 24at4wn).· smr connector small r (product code: 1374.15.305 - lot: 2501649).· smr eccent.Glenosphere ø 36mm (product code:1376.15.031 - lot: 2504663).· tt augm.360 baseplate #s-r 7° (product code: 1375.15.507 - lot: 2436845).· smr glenoid peg tt small-r #m (product code: 1375.14.652 - lot: 2509278).· smr cementless finned stem (product code: 1304.15.160 - lot: 2409244) - not revised patient 76 years old.Event occurred in germany.
Additional Manufacturer Narrative
Investigation : check of dhrs did not highlight any pre-existing anomalies on the lot numbers (2108014, 2408956 and 2511464) involved.This is the first and only complaint received on this specific lot numbers.A final report will be submitted after the investigation is completed.

• Brand Name: BONE SCREWS
• Common Device Name: Cortical Bone Screw - Flattened Head Dia. 5 mm L. 30 mm
• Manufacturer (Section D): Limacorporate S.p.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50803163
• Report Number: 3008021110-2026-00363
• Device Sequence Number: 18306097
• Product Code: PHX
• UDI-Device Identifier: 08033390196901
• UDI-Public: 08033390196901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8432.15.030
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown