MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT; PLATE, FIXATION, BONE

Model Number	02.118.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 5 feet 9 inches the date of event was reported as (b)(6) 2018; it is unknown if that is the date the non-union and plate breakage occurred or the date it was discovered.Additional product code: hwc.Device has reportedly not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation as it is reportedly still implanted in the patient.Part 02.118.008, lot l593675: manufacturing location: bettlach.Release to warehouse date: september 27, 2017.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 experienced non-union of the right tibia/fibula due to variable angle locking compression (lcp) medial distal tibia plate that was broken.The patient was originally implanted with one (1) tibia plate, nine (9) locking screws and two (2) cortex screws on (b)(6) 2017.There was no surgical delay reported.No further additional information available.Concomitant devices reported: locking screws (part/lot unknown, quantity 9), cortex screws (part/lot unknown, quantity 2).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Event description and concomitant devices updated.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) 2018, the patient experienced non-union of the right tibia/fibula due to variable angle ¿locking compression (lcp) medial distal tibia plate that was broken.Old hardware was removed and replaced on (b)(6) 2018.The patient was originally implanted with (1) tibia plate, (9) locking screws and (2) cortex screws on (b)(6) 2017.There was no surgical delay reported.The patient outcome is unknown.Concomitant devices reported: locking screws (part number unknown, lot number unknown, quantity 9), cortex screws (part number unknown, lot number unknown, quantity 2).

• Brand Name: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/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: 7526415
• Report Number: 2939274-2018-52224
• Device Sequence Number: 19214556
• Product Code: HRS
• UDI-Device Identifier: 10886982037701
• UDI-Public: (01)10886982037701
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 02.118.008
• Device Catalogue Number: 02.118.008
• Device Lot Number: L593675
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/19/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/18/2018
• 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
• Patient Weight: 77