MAUDE Adverse Event Report: Synthes GmbH LCP Drill Sleeve 5 f/Drill Bits ø4.3; Guide, surgical, instrument

Catalog Number	323.042
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: LCP Drill Sleeve 5 f/Drill Bits ø4.3
• Common Device Name: Guide, surgical, instrument
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50793057
• Report Number: 8030965-2026-09455
• Device Sequence Number: 21193007
• Product Code: FZX
• UDI-Device Identifier: 07611819246607
• UDI-Public: (01)07611819246607(10)50024P4
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 323.042
• Device Lot Number: 50024P4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• 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