MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/26MM; SCREW, FIXATION, BONE

Model Number	02.231.226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, a patient received treatment for a left lateral femoral condyle fracture with a left condylar va-lcp plate 4.5-5.0, two (2) locking screws 5.0 variable angle in its distal part, and three (3) cortical screws of 4.5 in the diaphyseal portion.Additionally, part of the implants is fixed with two (2) cannulated screws of 4.5 mm of titanium from another supplier.There may be a possible incompatibility of materials since the plate and its screws are made of steel.The surgery was successfully completed.There was no reported patient consequence.This report involves one (1) 5.0mm variable angle lockng screw/slf-tpng/strdrv/26mm.This is report 5 of 6 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/26MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11517105
• Report Number: 8030965-2021-02117
• Device Sequence Number: 14504037
• Product Code: HWC
• UDI-Device Identifier: 10886982062055
• UDI-Public: (01)10886982062055
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.231.226
• Device Catalogue Number: 02.231.226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2021
• Initial Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 65