MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM RADIOLUC; NAIL, FIXATION, BONE

Catalog Number 03.043.029

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

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.H10 additional narrative: d2b: additional product code: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a procedure using our tn-a, we had an issue with the aiming arm (03.043.029).After inserting nail, we attached the aiming arm and we attempted to drill for the first medial to lateral locking screw.When doing so, the drill was not aligned with the hole and was drilling into the nail.After removing the trocar and taking off the aiming arm and then reconnecting the aiming arm and re-inserting the trocars, the same issue occurred.It was last used on (b)(6) 2024 by the surgeon.No adverse events were reported with the outcome of the procedure, it did delay the case and we ended up having to do perfect circles proximally in the nail.This report is for one (1) aim-arm radioluc this is report 1 of 1 for complaint (b)(4).

• Brand Name: AIM-ARM RADIOLUC
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19026195
• MDR Text Key: 339223657
• Report Number: 8030965-2024-04396
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07612334171108
• UDI-Public: (01)07612334171108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.043.029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - NAILS; UNK - SCREWS: LOCKING
• Patient Age: 31 YR
• Patient Sex: Female