MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 12 HOLES/226MM-RIGHT; PLATE,FIXATION,BONE

Model Number	240.044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not available for reporting.Implant/explant dates are not available.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient was originally treated with a bridging external fixation of the knee on an unknown date due to motor vehicular accident.The external fixation was removed.Then later the patient was plated with a locking compression plate (lcp) proximal tibia plate and screws on unspecified date.It was noted the patient was non-compliant and months later had a non-union and broken plate.The broken plate was removed without incident and a new plate was implanted.  concomitant devices reported: 5.0mm cannulated locking screw 65mm (part# 02.205.065, lot# unknown, quantity 2); 5.0mm cannulated locking screw 60mm (part# 02.205.060, lot# unknown, quantity 1); 5.0mm cannulated locking screw 55mm (part# 02.205.055, lot# unknown, quantity 1); 4.5mm cortex screw self-tapping 30mm (part# 214.830, lot# unknown, quantity 3); 4.5mm cortex screw self-tapping 28mm (part# 214.828, lot# unknown, quantity 1); 4.5mm cortex screw self-tapping 26mm (part# 214.826, lot# unknown, quantity 1).This is report 1 of 1 for (b)(4).
Event or Problem Description
Patient consequence was reported as unknown.
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.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: 4.5MM LCP PROXIMAL TIBIA PLATE 12 HOLES/226MM-RIGHT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7834804
• Report Number: 2939274-2018-53546
• Device Sequence Number: 19115063
• Product Code: HRS
• UDI-Device Identifier: 10886982164599
• UDI-Public: (01)10886982164599
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: 240.044
• Device Catalogue Number: 240.044
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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: 39 YR
• Patient Weight: 64