MAUDE Adverse Event Report: SYNTHES GMBH TI TOMOFIX(TM) LATERAL DISTAL FEMUR PLATE-4 HOLES/RIGHT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 440.864S

Device Problem Break (1069)

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

Event Date 09/27/2022

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.Patient identifier: (b)(6).Additional device product codes: hrs.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

Device report from synthes reports an event in colombia as follows: it was reported that during a procedure on september 27, 2022, the specialist decided to mold the plate since he said that it did not fit well.At the moment of molding it with two wrenches, the plate broke at its distal part.There was an unknown delay in surgery in relation to this event.The patient status was reported as good.No further information is available.This report involves one ti tomofix (tm) lateral distal femur plate-4 holes/right.This is report 1 of 1 for (b)(4).

Event Description

There was no further medical intervention required.

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.H3, h4, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot part number: 440.864s, lot number:743p898, manufacturing site: grenchen, release to warehouse date: 29 april 2022, expiry date: 01 april 2032.A manufacturing record evaluation was performed for the finished device 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: d9.Device returned.H3.Device evaluation.H6.Investigation codes.Investigation summary: 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 tomofix fempl lat dist r 4ho tan had no signs of breakage.However, there is a crack visible between two of the holes.No other issues were found.A dimensional inspection for the tomofix fempl lat dist r 4ho tan was not performed as is not applicable to the complaint condition.According to surgical technique guide, tomofix lateral distal femur plates, left (440.874) and right (440.864) precontoured to fit the lateral distal femur, the tapered end facilitates minimally invasive insertion, holes a, b, and 1 through 4 are combi holes and provide the flexibility of axial compression or fixed-angle locking, holes c, e, f and g are fixed-angle locking holes.Additionally, the surgical technique does not provide any bending instruments, therefore the plate should not be bent.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the tomofix fempl lat dist r 4ho tan would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: yes.Dimensional inspection: n/a.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: TI TOMOFIX(TM) LATERAL DISTAL FEMUR PLATE-4 HOLES/RIGHT
• 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): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15631730
• MDR Text Key: 304716702
• Report Number: 8030965-2022-08415
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K141796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 440.864S
• Device Lot Number: 743P898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 57 KG