MAUDE Adverse Event Report: Synthes GmbH 1.1MM THREADED GUIDE WIRE 150MM; Guide, surgical, instrument

Catalog Number	292.622
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: 1.1MM THREADED GUIDE WIRE 150MM
• Common Device Name: Guide, surgical, instrument
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Werk Balsthal (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50848777
• Report Number: 8030965-2026-09619
• Device Sequence Number: 13268300
• Product Code: FZX
• UDI-Device Identifier: 10886982180728
• UDI-Public: (01)10886982180728(10)170123P
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 292.622
• Device Lot Number: 170123P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown