MAUDE Adverse Event Report: SYNTHES GMBH GUIDE ROD Ø2.5 F/HOLLOW DRILL W/STOP L23; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.019.026
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When performing the entry point the specialist ignored the indication that he must align the starter bit with the guide.Therefore when pressure was applied with the motor it bent and broke, leaving part of it in the patient.Part of the guide remained in the proximal humerus and could not be removed.
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 medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: recaptured codes on h6 (medical device problem code).H3, h6: photo investigation: the product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that ¿03.019.026, guide rod ø2.5 f/hollow drill w/stop l23¿ has broken.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.For the other reported event, the reported condition cannot be confirmed as the provided evidence was not sufficient to confirm the reported event of embedded device.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the guide rod ø2.5 f/hollow drill w/stop l23 would contribute to the complained device issue.Based on the investigation findings, guide rod ø2.5 f/hollow drill w/stop l23 was broken because of component failure, and 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 complaint condition.As part of medtech orthopedics 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.Device history review (dhr): part: 03.019.026-15; lot: 51879p5; manufacturing site: balsthal; release to warehouse: 03-mar-2025.A dhr evaluation was performed for the finished device article #03.019.026-15, lot #51879p5, and no non-conformance's were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GUIDE ROD Ø2.5 F/HOLLOW DRILL W/STOP L23
• 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 ; 9083863534
• MDR Report Key: 23457401
• Report Number: 8030965-2025-10981
• Device Sequence Number: 8073927
• Product Code: FZX
• UDI-Device Identifier: 07611819427518
• UDI-Public: (01)07611819427518(10)51879P5
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,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: 03.019.026
• Device Lot Number: 51879P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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