MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PL 9 HOLES/RIGHT; APPLIANCE,FIXATION,NAIL

Model Number	241.444
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2020, the surgeon removed a broken 3.5mm locking compression plate anterolateral distal tibia plate 9 holes/right and four (4) screws.The surgeon left the part of the plate and three (3) screws still in patient.This was a non union case so the surgeon used a smith and nephew nail to fix the patient.The four (4) screws were not broken and removed successfully.The reason that the plate and three (3) screws still in the patient was as mentioned, the patient had a non union so the plate and three (3) screws helped to stabilize the ankle joint and surgeon implanted a smith and nephew tibia nail above the plate and screws.The procedure was completed successfully.Surgical delay was unknown.There is no patient consequence reported.Concomitant device reported: 3.5mm locking screw self-taping with stardrive (tm) recess 28mm (part #: 212.110, lot #: unknown, quantity: 2).3.5mm cortex screw self-tapping 28mm (part #: 204.828, lot #: unknown, quantity: 2).Unknown screw: trauma (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) 3.5mm lcp® anterolateral distal tibia pl 9 holes/right.This is report 1 of 1 for (b)(4).
Additional 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: d7.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 ANTEROLATERAL DISTAL TIBIA PL 9 HOLES/RIGHT
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10629627
• Report Number: 2939274-2020-04494
• Device Sequence Number: 3205438
• Product Code: KTT
• UDI-Device Identifier: 10886982167071
• UDI-Public: (01)10886982167071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 241.444
• Device Catalogue Number: 241.444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM CORTEX SCREW SELF-TAPPING 28MM.; 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS.; UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention