MAUDE Adverse Event Report: SYNTHES GMBH 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS; NAIL, FIXATION, BONE

Catalog Number 03.010.436

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 12/26/2023

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: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2023, the little nub on the long insertion handle that allows the aiming arm to latch onto the long insertion hand broke.Fragments were generated but were easily removed.The aiming arm will no longer attach.The tip of 14.5mm insertion sleeve is bent and no longer allows the trocar or wire guide to fit inside.The surgery was successfully completed with minimal surgical delay.This report is for one (1) 14.5mm protection slv straight for 12mm-13mm nails.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 14.5MM PROTECTION SLV STRAIGHT FOR 12MM-13MM NAILS
• 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 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18519983
• MDR Text Key: 333461890
• Report Number: 8030965-2024-00889
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068774
• UDI-Public: (01)10886982068774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111667
• 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: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• 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 - TROCAR
• Patient Age: 78 YR
• Patient Sex: Female