MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP(TM) PROXIMAL TIBIA PL 16 HOLES/298MM RT-STERILE; PLATE, FIXATION, BONE

Model Number	240.048S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown on what date the plate broke.Lot number is unknown.Date of implantation is unknown.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.No code available used for patient undergoing surgery to remove the broken plate.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 the patient underwent removal of a locking compression plate (lcp) proximal tibia plate and unknown screws due to broken plate on (b)(6) 2018.It is unknown when the devices were originally implanted.Implants were successfully removed.There was no surgical delay reported.There were no fragments generated from a broken device and did not require any medical interventions.The procedure was successfully completed and the patient was in stable condition.Concomitant device: unknown screws (part# unknown, lot# unknown, quantity unknown).This report is for a 4.5mm lcp(tm) proximal tibia pl 16 holes/298mm rt-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM LCP(TM) PROXIMAL TIBIA PL 16 HOLES/298MM RT-STERILE
• 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: 7545458
• Report Number: 2939274-2018-52311
• Device Sequence Number: 1862887
• Product Code: HRS
• UDI-Device Identifier: 10886982164674
• UDI-Public: (01)10886982164674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 240.048S
• Device Catalogue Number: 240.048S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention