MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS; NAIL, FIXATION, BONE

Catalog Number	03.010.435
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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 report, a follow-up report will be filed as appropriate.H11 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.
Event or Problem Description
It was reported that the patient underwent orif surgery for tibial shaft fractures.The surgery was performed using tna and started with standard techniques using a suprapatellar approach.A solid protection sleeve was used, and the medullary canal reamer procedure was performed.The nail was then inserted without removing the metal protection sleeve.The nail was advanced to the distal tibia once, but it was removed to restart the reaming procedure.When removing the nail, it became stuck in the protection sleeve, and it was determined that it would be impossible to detach the nail from the sleeve during surgery, so one size shorter nail was inserted instead.The surgery was completed successfully within 30 minutes¿ delay.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: 12.0MM PROTECTION SLV STRAIGHT FOR 8MM-11MM NAILS
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23351852
• Report Number: 8030965-2025-10580
• Device Sequence Number: 21087192
• Product Code: JDS
• UDI-Device Identifier: 07611819501744
• UDI-Public: (01)07611819501744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111667
• 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

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: 03.010.435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown