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
Event or Problem Description
It was reported that during the surgical procedure, the specialist proceeded with the placement of the 1.1 mm threaded tip guides for the subsequent fixation of the cannulated screw; however, during the maneuver, the distal end of one of the guides fractured, becoming lodged in the patient.In view of this event, the surgeon made the corresponding attempts to remove the fragment, but determined that the extraction was not feasible, opting to leave the tip in place to avoid further complications.It should be noted that the situation was handled by the specialist without generating setbacks, there was no discomfort on his part and the intervention continued without registering delays in the scheduled surgical time.
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.

• 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): 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: 50945587
• Report Number: 8030965-2026-09940
• Device Sequence Number: 9623980
• Product Code: FZX
• UDI-Device Identifier: 10886982180728
• 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: Foreign,Health Professional,Distributor
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female