MAUDE Adverse Event Report: SYNTHES GMBH INSERT FOR FNS INSERTION HANDLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 03.168.009

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

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent the femoral neck fracture osteosynthesis for femoral neck fracture with the products in question.During the surgery, the surgeon followed the guidewire insertion, measurement, and drilling procedures, sliding and attaching the plate to the insertion handle with the 2hole plate and 95 mm neck bolt set.He inserted the inserter from behind and when he did the screw installation, a nurse said it was too hard and the screw would not turn.They tried several times to reinsert them, but they never seemed to go in, so they dismantled everything and checked the implants visually.Neck bolt and plate conformity was not a problem.There was significant resistance when inserting the plate and inserter.They pushed harder and managed to get them in, so they again attempted to attach the implants using a combination of handle and inserter.It was obvious to the naked eye that the inserter was more advanced than at first, so they used the t-chuck handle of the jacobs chuck to forcefully turn the c screw.Although forceful, the installation was completed, and since there were no apparent problems, the procedure was continued as is.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for an insert for fns insertion handle.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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: initial reporter is a synthes employee.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.

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.H10 additional narrative: h3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the ins f/insertion handle.A dimensional inspection was performed for the ins f/insertion handle and met specifications.A functional test was unable to be performed since the mating device was not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the ins f/insertion handle was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: device history record )dhr) review conducted: part# 03.168.009, lot # 180293-301, manufacturing site: werk selzach logistik, release to warehouse date: 14 feb 2019, supplier: (b)(4), expiration date: n/a, a manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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.

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: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERT FOR FNS INSERTION HANDLE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16444202
• MDR Text Key: 310262679
• Report Number: 8030965-2023-02366
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982274434
• UDI-Public: (01)10886982274434
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.168.009
• Device Catalogue Number: 03.168.009
• Device Lot Number: 180293-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• 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: PL 2HO F/FEM NECK SYST TAN; UNK - GUIDE/COMPRESSION/K-WIRES