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

Model Number	02.112.518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a hardware removal due to a malunion and infection.Moreover, the patient had experienced delayed healing.Originally, the patient was implanted with one (1) 3.5mm locking compression plate (lcp) low bend medial distal tibial plate, three (3) unknown 3.5mm locking screws, two (2) unknown 3.5mm cortex screws, one (1) 2.7mm lcp plate, four (4) unknown 2.7mm cortex screws and two (2) unknown 2.7mm lag screws on an unknown date.During revision, all hardware were successfully removed and the patient was revised with 3.5mm cortex screw with washer and a variable-angle (va) anteromedial distal tibia plate.Patient outcome is unknown.The complaint involves 13 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints : (b)(4).(b)(4) captures the post-op event due to malunion and infection while (b)(4) captures the intraoperative event wherein the tip of the two (2) stardrive screwdriver shafts were twisted on final tightening of the screws.This complaint involves nine (9) devices.This report is 1 of 9 for (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/8H/RIGHT/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: 8876326
• Report Number: 2939274-2019-59615
• Device Sequence Number: 11410021
• Product Code: HRS
• UDI-Device Identifier: 10886982034557
• UDI-Public: (01)10886982034557(
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.112.518
• Device Catalogue Number: 02.112.518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR