MAUDE Adverse Event Report: Synthes GmbH BLADE/SCREW GUIDE SLEEVE; Guide, Surgical, Instrument

Catalog Number	03.037.017
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > pc-002256703 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.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: photo investigation: an x-ray of the product was provided to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.¿visual inspection of the of the x-ray found the tip of the device could be identified mounted with the implantation system, however no damage or deformation was observed.The reported complaint was not confirmed based on the evaluation results.Although no product defect was identified, other circumstances during device use may have contributed to the reported condition, which could not be replicated during laboratory testing.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during the proximal locking portion of the tfna case, surgeon inserted a 10mm cannulated tapered drill bit and noticed some ¿chatter¿.He then inserted the 6/9 drill bit and it made more pronounced chatter.Upon pulling the 6/9 drill bit out, they took x rays and noticed fragments of the tip of the drill bit in the femoral neck.They also inspected the 10mm cannulated tapered drill bit and noticed that the tip of the drill bit was broken as well with fragments in the patient¿s femoral neck.Attempts were made to remove the fragments, but some remained in the patient.It was further reported that the 3.2mm wire guide sleeve, blade/screw guide sleeve or 3.2mm trocar may be bent and was causing issue.New drill bits and proximal locking triple sleeves were opened, and the procedure was completed with a reported 20-minute delay.The case was completed without incident.There was no patient harm.

• Brand Name: BLADE/SCREW GUIDE SLEEVE
• Common Device Name: Guide, 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 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50885561
• Report Number: 8030965-2026-09741
• Device Sequence Number: 21288824
• Product Code: FZX
• UDI-Device Identifier: 10886982070333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 03.037.017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• 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