MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM/8.0MM PROTECTION SLEEVE 188MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.063
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent orif surgery for proximal humerus fractures.During the procedure, one distal hole was drilled and confirmed by imaging to have passed through the nail hole.While drilling another hole, the drill bit interfered with the nail.Although recovery methods such as lightly tapping with a plastic hammer, creating a pilot hole with a k-wire, and manually fine-tuning the sleeve were attempted, the drill bit would not pass through the nail.As a result, no screw was inserted into that hole and fixation was performed with one distal locking screw.The procedure was completed successfully within a thirty (30) minute delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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: added: d9.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: added: g1, h4.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 12.0mm/8.0mm protection sleeve 188mm was observed with normal wear due to use and general corrosion on the surface device.However these condition should not affect the ability to assemble or disassemble the mating devices.A dimensional inspection for the 12.0mm/8.0mm protection sleeve 188mm was not performed as it is not applicable to the complaint condition.An interactional test was performed with the mating devices (aim-arm, drill and trocar) received in this complaint and no misalignment was observed, the devices were able to pass through the holes and they remain stable.The complaint condition was not able to be replicated.The potential cause is being attributed to cleaning/sterilization methods.As per se_023827 rev ap, during cleaning, only use cleaning agents that are labelled for use on medical devices and in accordance with the manufacturer¿s instructions (e.G.Temperature, contact time, and rinse time).Cleaning agents with a used dilution ph of within 7¿9.5 are recommended.Highly alkaline conditions (ph >11) can damage components/devices, such as aluminum materials.Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products).Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes.The overall complaint was not confirmed as the observed condition of the 12.0mm/8.0mm protection sleeve 188mm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: product code:03.010.063, lot number: 3767977, release to warehouse date :08.Jun.2011, manufacturing site: werk hägendorf.A manufacturing record evaluation was performed for the finished article lot 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: 12.0MM/8.0MM PROTECTION SLEEVE 188MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24400984
• Report Number: 8030965-2026-01744
• Device Sequence Number: 8224071
• Product Code: LXH
• UDI-Device Identifier: 07611819760905
• UDI-Public: (01)07611819760905(10)3767977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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: 03.010.063
• Device Lot Number: 3767977
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/09/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2011
• 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: Female