MAUDE Adverse Event Report: SYNTHES GMBH 3.2MM WIRE GUIDE SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.037.018
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insert-handle, aim-arm 125° f/stat dist lock, blade/screw guide sleeve, drillsl yell, trocar yell, buttress/compr-nut, screw inserter, connecscr f/tfna helical blade+scr, dhs® triple reamer, complete, with long reamer, and flex sft connector for use jacobs chuck were associated with issues including improper positioning of guide wires by insertion handles and guides, deformation of t handles for lag screws making insertion difficult, damage to the dhs reamer rendering it unsafe for use, reamer adapters becoming jammed, and a bent radiographic ruler.The event occurred pre-operatively and did not involve the patient, nor did it occur during sterile processing or field inspection.
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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
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.H11 additional narrative: added: d10 h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.2MM WIRE GUIDE SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24363775
• Report Number: 8030965-2026-01545
• Device Sequence Number: 12069104
• Product Code: LXH
• UDI-Device Identifier: 10886982070340
• UDI-Public: (01)10886982070340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 03.037.018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AIM-ARM 125° F/STAT DIST LOCK; BLADE/SCREW GUIDE SLEEVE; BUTTRESS/COMPR-NUT; CONNECSCR F/TFNA HELICAL BLADE+SCR; DHS® TRIPLE REAMER, COMPLETE, WITH LONG REAMER; FLEX SFT CONNECTOR FOR USE JACOBS CHUCK; INSERT-HANDLE; SCREW INSERTER; TROCAR YELL
• Patient Sex: Unknown