MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM; PLATE. FIXATION, BONE

Model Number	02.112.530
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure.For medical device removal, malunion and nonunion.A review of the device history record: device history lot- part number: 02.112.530; lot number: r259113l part manufacture date: n/a; manufacturing location: n/a; part expiration date: n/a; nonconformance noted: n/a.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.Device history batch null, device history review a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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) 2019, the patient underwent a revision of open reduction internal fixation (orif) distal tibia fracture and hardware removal due to malreduction and nonunion.There was no broken hardware.The fracture was malreduced.Initially, the following devices; one (1) locking compression plate (lcp) bend medial distal tibia plate, three (3) 3.5 unknown cortex screws and seven (7) unknown locking screws were implanted on (b)(6) 2019.The surgeon verbalized that the patient had been treated somewhere else and this is how the fracture had looked post-op.He stated that it was not a hardware issue.Most proximal screws in shaft had been placed very posterior in the segment and in some cases transcortical.Removed existing hardware and placed tibial nail with bone graft.There was no surgical delay.Procedure outcome and patient status are unknown.This complaint involves ten (10) devices.This report is for one (1) 3.5mm lcp low bend medial dstl tibia plate/14h/right/239mm.This report is 1 of 10 for (b)(4).

• Brand Name: 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/14H/RIGHT/239MM
• 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: 8927474
• Report Number: 2939274-2019-60056
• Device Sequence Number: 2048839
• Product Code: HRS
• UDI-Device Identifier: 10886982034670
• UDI-Public: (01)10886982034670
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K013248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/26/2019

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: 02.112.530
• Device Catalogue Number: 02.112.530
• Device Lot Number: R259113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 79