MAUDE Adverse Event Report: Synthes GmbH 3.5 VOLT(TM) NON-LCKNG DRL GUIDE FOR 2.5 MM DRILL BITS; Guide, surgical, instrument

Catalog Number	03.535.212
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the set was being put together when it was found that the handle and drill sleeve had separated.It is unknown where the handle went.
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.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: investigation summary the product was not returned to depuy synthes; however, photos were received for review.The photo investigation revealed that ' 03.535.212, volt drill guide 3.5 f/drill bits ø2.5m has sleeve separated from the rod and rod is missing.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.For missing components, a definitive root cause cannot be established since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the volt drill guide 3.5 f/drill bits ø2.5 would contribute to the complained 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 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 lot 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 reassessed.

• Brand Name: 3.5 VOLT(TM) NON-LCKNG DRL GUIDE FOR 2.5 MM DRILL BITS
• Common Device Name: Guide, surgical, instrument
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): Bridgewater Distribution; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50858539
• Report Number: 8030965-2026-09655
• Device Sequence Number: 21209342
• Product Code: FZX
• UDI-Device Identifier: 07612334236715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 03.535.212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/22/2026
• 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