MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/LEFT/161MM; PLATE,FIXATION,BONE

Model Number	02.112.519
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as (b)(6).Date of event: date of postoperative plate breakage is unknown.Implanted date: original implant date is (b)(6) 2017; exact date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Concomitant medical products: therapy date is (b)(6) 2017; exact date is unknown.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 the patient underwent revision of a medial distal tibia plate and nine screws on (b)(6) 2017 due to nonunion.The plate and six 3.5 cortical and three 3.5 locking screws were originally implanted in february 2017 due to a workman¿s compensation injury.The nonunion was discovered post-operatively via x-ray on an unknown date and the surgeon requested revision surgery.By the time the revision surgery could be scheduled through workman¿s compensation, the plate and two cortical screws were broken (heads of the screws were broken off).The revision surgery was successfully completed with no delay.The patient was revised to a tibial nail with good outcome.Concomitant devices reported: 3.5 locking screws (part# unknown, lot# unknown, qty 3), 3.5 cortical screws (part# unknown, lot# unknown, qty 4).This report is for one (1) 3.5mm lcp low bend medial dstl tibia plate/8h/left/161mm.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/LEFT/161MM
• 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: 7075429
• Report Number: 2939274-2017-50113
• Device Sequence Number: 10994628
• Product Code: HRS
• UDI-Device Identifier: 10886982034571
• UDI-Public: (01)10886982034571(10)H077316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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: 02.112.519
• Device Catalogue Number: 02.112.519
• Device Lot Number: H077316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 12/01/2017
• 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
• Patient Weight: 106