MAUDE Adverse Event Report: SYNTHES GMBH TNA CONNECTING TUBE ROTATING TNA AIMING ARM; NAIL, FIXATION, BONE

Catalog Number	SD03.043.031
Medical Device Problem Code	Device-Device Incompatibility (2919)
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that connect f/expert han f/03.008.007, tna connecting tube tna arm, and aiming arm assembly tna arm were involved in an event where the strike cap and tna connecting tube became wedged together, making it impossible for staff to disassemble the devices.Attempts to remove the components placed significant stress on the patient, leading to a change in the removal approach.All three pieces remained stuck together after the procedure.There was no reported patient consequence or clinical symptoms as a result of the event.
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: h3, h6: photo investigation the product was not returned to depuy synthes, however photos were provided for review.The device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however, the provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the tna connecting tube tna arm 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.There is no indication that a design or manufacturing issue has caused the 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 lot: part number: sd03.043.031-us, lot number: 6660p99 , part manufacture date: 04/30/2024, manufacturing location: brandywine , part expiration date: n/a , nonconformance noted: jbl-nr-0027613.A review of the device history record of this lot revealed no complaint-related anomalies.The tna connecting tube rotating aiming arm was made to sd03_043_031 revision a.Nonconformance jbl-nr-0027613, initiated 03/21/2024 at op.0020 srg/srt inspect, identified characteristics out of tolerance as documented on the f-s1187 inspection sheet.After rework and reinspection at the vendor arch medical solutions, (55) of (56) parts were dispositioned use-as-ls (uai) per the 100329212, use as-is technical justification form provided by jjmd srg engineering.One (1) part was scrapped.Based on the disposition at the time of release, there were no issues documented during manufacture that would contribute to this complaint condition.Device history review: nonconformance jbl-nr-0027613, initiated 03/21/2024 at op.0020 srg/srt inspect, identified characteristics out of tolerance as documented on the f-s1187 inspection sheet.After rework and reinspection at the vendor arch medical solutions, (55) of (56) parts were dispositioned use-as-ls (uai) per the 100329212, use as-is technical justification form provided by jjmd srg engineering.One (1) part was scrapped.Based on the disposition at the time of release, there were no issues documented during manufacture that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TNA CONNECTING TUBE ROTATING TNA AIMING ARM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 24365754
• Report Number: 8030965-2026-01559
• Device Sequence Number: 17459401
• Product Code: JDS
• UDI-Device Identifier: 10886982344366
• UDI-Public: (01)10886982344366(10)6660P99
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: SD03.043.031
• Device Lot Number: 6660P99
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIMING ARM ASSEMBLY TNA ARM.; CONNEC F/EXPERT HAN F/03.008.007.
• Patient Sex: Unknown