MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE; NAIL, FIXATION, BONE

Model Number 04.043.245S

Device Problem Material Deformation (2976)

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

Event Date 05/23/2022

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.Additional narrative: additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 that during a procedure on (b)(6) 2022, while implanting a 10x375 synthes tibial advance nail, the pin that held the spring in place on the impactor handle had broken.This allowed for the release mechanism to move freely on the impactor.The surgeon noted that the aiming arm was moving independently of the nail, and they attempted to re-tighten the connecting screw, but it was not loose.Upon further inspection of the nail/aiming arm attachment point, it looked like the nail was beginning to splay at its proximal end.The surgeon was able to impact the rest of the nail until it was fully inserted into the patient.The surgery was completed successfully without any other complications.This report is for a tibial nail-advanced / 10mm 375mm / sterile.This is report 1 of 2 for (b)(4).

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: h6: a device history record (dhr) review was conducted: part # 04.043.245s.Lot # 679p812.Manufacturing site: jabil bettlach.Release to warehouse date: 22.March.2022.Expiry date: 29.February.2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.

• Brand Name: TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14747733
• MDR Text Key: 301593775
• Report Number: 9612488-2022-00019
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982297808
• UDI-Public: (01)10886982297808
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.043.245S
• Device Catalogue Number: 04.043.245S
• Device Lot Number: 679P812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRIVING CAP; UNK - BIOMATERIAL - CEMENT: TRAUMACEM; UNK - INSERTION INSTRUMENTS: CONNECTING: TRAUMA; UNK - NAIL INSERTION HANDLES
• Patient Sex: Male