MAUDE Adverse Event Report: Synthes GmbH VOLT Dble Drill Guide f/Drill Bits ø2; Guide, surgical, instrument

Catalog Number	03.527.206
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date about damaged shipment.Upon manufacturers investigation it was noted that one guide sleeve was observed detached from the weld area.
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.H3, h6: part: 03.527.206.Synthes lot: 3273124.Supplier: (b)(4).Release to warehouse date: 06 dec, 2025.Expiry date: n/a.No ncrs generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed the device was observed inside its packaging.One guide sleeve was observed detached from the weld area.The supplier has increased their inspection frequency of the weld, to assess the design, packaging, and risk file for the drill guide family.The observed condition is consistent with a random component failure that may have been caused by exposure to unintended forces.Therefore, the suspected cause is traced to transport/storage.Information has been reviewed and determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of the depuy synthes device after it was released for distribution.However, a deliver service issue (dsi) is indicated and addressed internally within a local quality management system.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the volt dble drill guide f/drill bits ø2 would have contributed to the device issue.Based on the investigation findings, the product issue has been addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: VOLT Dble Drill Guide f/Drill Bits ø2
• 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: 50752302
• Report Number: 8030965-2026-09218
• Device Sequence Number: 21172522
• Product Code: FZX
• UDI-Device Identifier: 10886982336354
• UDI-Public: (01)10886982336354(10)3273124
• Combination Product (Y/N): N
• 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: 03.527.206
• Device Lot Number: 3273124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2025
• 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