MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP(TM) ANTEROLATERAL DISTAL TIBIA PL 21 HOLES/LEFT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 441.457

Device Problem Material Deformation (2976)

Patient Problem Fall (1848)

Event Date 12/21/2022

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(4) 2022, the patient underwent orif for tibial diaphyseal fracture with the product in question and autologous bone grafting was performed on the patient's bone defects.The patient was rehabilitated with partial load, but on (b)(6) 2022, the patient fell and the plate was bent and damaged.On (b)(6) 2022, reoperation was performed to remove the plate and fix with tna.The surgeon commented that the product damage was unavoidable because of the patient's fall.No further information is available.This report is for a 3.5mm ti lcp(tm) anterolateral distal tibia pl 21 holes/left.This is report 1 of 1 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.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 3.5MM TI LCP(TM) ANTEROLATERAL DISTAL TIBIA PL 21 HOLES/LEFT
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16216265
• MDR Text Key: 307814430
• Report Number: 8030965-2023-00705
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982222084
• UDI-Public: (01)10886982222084
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000684
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 441.457
• Device Catalogue Number: 441.457S
• Device Lot Number: 3L51677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 65 KG