MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	292.68
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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 on an unknown date that at one of their hospitals they have had an plethora of trays begin peeling.The sterile processing department has taken note of this and flags the trays as being unsterile and unable to be sterilized until trays were replaced.Have attached the sets 6.5/7/3 cannulated screws in a quantity of 2.In addition to the cannulated screws, there were more sets in the file of this complaint that weren't able to be attached.The sets include: 2.4/2/7 va distal radius, tfna implants x2, tfna insertion , tfna opening/locking x2, orthopaedic cable, 4.5 va condy plates, 4.5 va condy instr.& screws x2, 4.5 va condy aiming instr.X2, lcp small fragment x3, 2.7/3.5 va elbow, and large ex-fix x2.
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the shaft was deformed.No other issue was identified.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A functional test was unable to be performed due to the post-manufacturing damage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the 2.8mm threaded guide wire- trocar point 300mm would have contributed to the device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM
• 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 ; 9083863534
• MDR Report Key: 25509535
• Report Number: 8030965-2026-06208
• Device Sequence Number: 18771572
• Product Code: FZX
• UDI-Device Identifier: 10886982180803
• UDI-Public: (01)10886982180803
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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

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: 292.68
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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