MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA LCK SCRW/SLF-TP/STRD/60; SCREW, FIXATION, BONE

Model Number	02.127.160
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product code: hrs.Due to intra-operative issues, the device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation as it was reportedly discarded.Without a lot number the device history records review could not be completed.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 on (b)(6) 2018, during a tibia plateau fracture repair, a locking screw went through a variable angle - locking compression proximal tibia plate (lcp).Initially, the surgeon used a power driver with torque limiter to implant six (6) locking screws into the plate.The surgeon then used stardrive screwdriver from a locking small fragment set to final tighten the screws.On (b)(6) 2018, intra-operatively, x-ray was done and it confirmed that one of the screws had gone through the plate.The surgeon then backed the screw out and discarded it.The screw was intact, but the hole in the plate had stripped after the surgeon tightened without torque limiter.Instead of a clover shape, it appeared as a circle.That hole was left empty.There were also supplemental screws that were used to provide a temporary fixation on the side of the tibia but they were removed as they were never intended on being implanted.There was an approximate one-minute surgical delay to remove the screw.The final construct included one (1) plate and five (5) screws.The procedure was completed successfully.Patient outcome was stable.Concomitant devices reported: torque limiting attachment (part 511.773, lot unknown, quantity 1), locking screws (part 02.127.170, lot unknown, quantity 4), locking screw (part 02.127.156, lot unknown, quantity 1), and stardrive screwdriver (part 314.115, lot unknown, quantity 1).(b)(4).

• Brand Name: 3.5 VA LCK SCRW/SLF-TP/STRD/60
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7583968
• Report Number: 2939274-2018-52444
• Device Sequence Number: 14110816
• Product Code: HWC
• UDI-Device Identifier: 10886982043344
• UDI-Public: (01)10886982043344
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.127.160
• Device Catalogue Number: 02.127.160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1