MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP METAPHYSEAL PLATE 10 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION

Model Number	223.410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, during post-op sales consultant was notified that surgeon was going to be removing a plate from a distal femur because of pain.The hardware was removed successfully.Additionally, during the removal, a screw driver shaft from the screw removal set was noticed to be bent.It was discarded and a new one will be purchased by the hospital.This report is for one (1) 3.5mm lcp metaphyseal plate 10 holes this is report 1 of 12 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Appliance, fixation, nail/blade/plate combination, multiple component, metal composite complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 LCP METAPHYSEAL PLATE 10 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16415111
• Report Number: 8030965-2023-02091
• Device Sequence Number: 3504659
• Product Code: LXT
• UDI-Device Identifier: 10886982157621
• UDI-Public: (01)10886982157621
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 223.410
• Device Catalogue Number: 223.410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMALL HEXAGONAL SCREWDRIVER SHAFT; UNK - SCREWS: 6.5 MM CANCELLOUS; UNK - SCREWS: CORTICAL : TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 71 KG