MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA P TIB S BEND/4H/87/LT; PLATE,FIXATION,BONE

Model Number	02.127.211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event is unknown.Additional classification code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device: part: 02.127.211, lot: 9947284, manufacturing site: (b)(4), release to warehouse date: 13.May 2016.No ncrs were generated during production.Review of the device history record 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 a patient had a proximal tibia revision surgery performed on (b)(6) 2018 for removal hardware proximal tibia plate due to pain.The one (1) proximal tibia plate, four (4) 3.5 mm variable angle locking screws, and three (3) 3.5 mm cortex screws were removed whole and intact.The original surgery was performed on (b)(6) 2017.The revision surgery was successfully completed.No surgical delay or patient harm were reported.Patient outcome was reported as complete.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5 VA P TIB S BEND/4H/87/LT
• 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: 7435943
• Report Number: 2939274-2018-51758
• Device Sequence Number: 1705169
• Product Code: HRS
• UDI-Device Identifier: 10886982043481
• UDI-Public: (01)10886982043481
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• 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
• Report Date (Section B): 03/28/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.127.211
• Device Catalogue Number: 02.127.211
• Device Lot Number: 9947284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/17/2018
• 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 Age: 32 YR
• Patient Weight: 83