MAUDE Adverse Event Report: SYNTHES GMBH PROTECTION SLEEVE/ Ø 11/8; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.045.019
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a problem with drilling a hole for the locking screw due to pressure on the aiming arm system.Surgery was completed successfully with no delay.The surgeon stated they repeatedly came across the nail while drilling.The drilling of the oblique lock was not a problem, the problem was with the connection between the target bar and the nail.It could only be released from the nail with extreme exertion at the end.In the surgeon's opinion, it was initially correctly mounted, which could have contributed to the problem, that they lowered the leg for the distal, oblique locking, that is, the knee stretched and thus certainly brought tension to the connection nail/target bracket.
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.
Event or Problem Description
Additional information was received and states that: a.What approach was used for the tibial nail procedure (suprapatellar, infrapatellar?) infrapatellar b.Please confirm which hole was being targeted when the problem of hitting the nail occurred (proximal static 1, proximal static 2, dynamic, proximal oblique 1, proximal oblique 2).Proximal static 1, dynamic.C.It was reported that the procedure was successfully completed.Please explain what steps were taken in order to achieve a successful outcome.Proximal oblique holes and free hand locking.D.What was the angle of knee flexion, and did it change during surgery? flexion 45, 10, yes.E.Was the compression screw used? no.F.Was the nail over inserted? if yes, how far? no.
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: a3a, b5, d10 (concomitant).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: b5.Added: b14 (to capture dhr), g1 manufacturing site.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history review (dhr): part number: 03.045.019, lot number: 441p962, manufacturing site: hägendorf, release to warehouse date: 22-dec-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.
Event or Problem Description
Additional information was received and stated there were no allegation against the locking screw.

• Brand Name: PROTECTION SLEEVE/ Ø 11/8
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF; im bifang 6; hägendorf CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21283652
• Report Number: 8030965-2025-01164
• Device Sequence Number: 7908446
• Product Code: LXH
• UDI-Device Identifier: 07612334167880
• UDI-Public: (01)07612334167880(10)441P962
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: 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: 03.045.019
• Device Lot Number: 441P962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/07/2025; 03/24/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/13/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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: UNK - GUIDES/SLEEVES/AIMING; UNK - SCREWS: LOCKING
• Patient Sex: Unknown