MAUDE Adverse Event Report: SYNTHES GMBH 2.7 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 2.0MM DRILL BITS; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.527.206
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2026
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that ' 03.527.206, 2.7 volt(tm) crtx/lckng drl gd f/2.0 db has broken into pieces.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 2.7 volt(tm) crtx/lckng drl gd f/2.0 db would contribute to the complained device issue.Based on the investigation findings, the ¿2.7 volt(tm) crtx/lckng drl gd f/2.0 db¿ has broken into pieces because of unintended force, 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 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.Device history part # 03.527.206 synthes lot # 3253509 supplier lot # 3253509 release to warehouse date: 21 jul 2025 expiration date; na supplier: viant (b)(4).No ncr's generated during production.
Event or Problem Description
It was reported on march 14, 2026 during an orif of femur the drill guide broke and was unable to use.Also, volt depth gauge stem was bent beyond repair.Both instruments were replaced from other sets quickly with minimal delay to the case patient outcome was good.

• Brand Name: 2.7 VOLT(TM) CRTX/LCKNG DRILL GUIDE FOR 2.0MM DRILL BITS
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24758052
• Report Number: 8030965-2026-03059
• Device Sequence Number: 12954760
• Product Code: FZX
• UDI-Device Identifier: 10886982336354
• UDI-Public: (01)10886982336354(10)3253509
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,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: 03.527.206
• Device Lot Number: 3253509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/10/2026; 06/12/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/21/2026; 06/11/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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