MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 36MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	214.836
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional pro-code: hwc.Without a valid lot number the device history records review could not be completed.Complainant part is not expected to be returned for manufacturer review/investigation, as part was discarded by the facility.(b)(4).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 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
It was reported that on unknown date, patient underwent a orif distal femur procedure.It was noted that the plate broke at hole number 8 and also the 3 - 4.5mm cortical screws broke.It is unknown if fragments were generated.It is unknown if the procedure is completed.No patient consequences noted.Devices were involved: 214.836 (4.5mm cortex screw self-tapping 36mm), quantity: 3, 02.231.275 (5.0 va lockng scr slf-tpng/sd/75), quantity: 5-6, a plate.This complaint involves ten (10) devices.This report is for one (1) 4.5mm cortex screw self-tapping 36mm.This report is 3 of 10 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 36MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12063850
• Report Number: 2939274-2021-03227
• Device Sequence Number: 4218878
• Product Code: KTT
• UDI-Device Identifier: 10886982154675
• UDI-Public: (01)10886982154675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREADM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.836
• Device Catalogue Number: 214.836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR