MAUDE Adverse Event Report: SYNTHES GMBH 4.3MM THREADED LCP(TM) DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	323.042
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
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: h3, h6: part number: 323.042 lot number: 30p1444 manufacturing site: hägendorf release to warehouse date: 24-dec-2019.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation of " 323.042, lcp drill sleeve 5 f/drill bits ø4.3" revealed that the pin of the device has broken.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trialing.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the lcp drill sleeve 5 f/drill bits ø4.3 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to 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 orthopaedics 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.
Event or Problem Description
It was reported that a drill guide breaks when adapting it to the plate.

• Brand Name: 4.3MM THREADED LCP(TM) DRILL GUIDE
• 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: 22185352
• Report Number: 8030965-2025-05824
• Device Sequence Number: 8571052
• Product Code: FZX
• UDI-Device Identifier: 07611819246607
• UDI-Public: (01)07611819246607(10)30P1444
• 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
• 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: 323.042
• Device Lot Number: 30P1444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2019
• 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