MAUDE Adverse Event Report: SYNTHES GMBH BUTTRESS/COMPR-NUT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.037.016
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that on 02 february, 2026 upon disengaging tfna lag screw drill/insert sleeve, the outer sleeve and buttress wheel would not disengage.Surgeon and scrub tech used a mallet to release it and caused the buttress wheel to cross thread with the outer sleeve.Surgery was delayed for 5 minutes due to the reported event.Malleted sleeve and wheel out, procedure was successfully completed.No fragments were generated.No patient consequences.
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: added: d4 (lot, expiration date), h4 corrected: d4 primary udi number 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: g1, h4.Added: d10.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nut is stripped at the distal end.An interaction was made between the buttress/compr-nut and the blade/screw guide sleeve and was found that devices were unable to be disassembled given the condition of the blade/screw guide sleeve, therefore, the reported condition was able to be replicated.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance; or by assembling the device in a misaligned position.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the buttress/compr-nut would have contributed 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 reported 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 review.Part number: 03.037.016-us.Lot number: 96p4881.Manufacturing site: hägendorf.Release to warehouse date: 28-april-2021.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances 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: BUTTRESS/COMPR-NUT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24369908
• Report Number: 8030965-2026-01572
• Device Sequence Number: 18587441
• Product Code: LXH
• UDI-Device Identifier: 10886982070326
• UDI-Public: (01)10886982070326(17)411231(10)96P4881
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 03.037.016
• Device Lot Number: 96P4881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/18/2026; 03/18/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 02/23/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BLADE/SCREW GUIDE SLEEVE
• Patient Sex: Unknown