MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/26MM; SCREW, FIXATION, BONE

Model Number	02.206.226
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of postoperative screw breakage is unknown.Explanted date: part of the screw remained in the patient¿s bone; device not considered explanted.Complainant device is not expected to be returned for manufacturer review/investigation.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 a patient had to undergo revision surgery on (b)(6) 2017 for removal of 2.7/3.5mm variable angle-locking compression (va-lcp) medial distal tibia plate/8 holes/left implanted on (b)(6) 2017.The hardware removal was due six broken screws and non-union.The heads of the two 3.5mm cortex screw 26mm, one 3.5mm cortex screw 28mm and three unknown locking screws were removed.The shaft of all these screws were retained in the patient and were not removed.Nothing was implanted during revision surgery as the surgeon just wanted to rule out the infection by removing the broken screws.The surgery was completed without any surgical delay and the patient was stable after the surgery.Concomitant devices reported: 2.7/3.5mm va-lcp medial distal tibia plate/8 holes/left (part # 02.118.007, lot # unknown, qty # 1).This report is for one (1) 3.5mm cortex screw 26mm.This is report 2 of 4 for complaint (b)(4).

• Brand Name: 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/26MM
• 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: 7173538
• Report Number: 2939274-2018-50117
• Device Sequence Number: 19056541
• Product Code: HWC
• UDI-Device Identifier: 10886982051042
• UDI-Public: (01)10886982051042(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K111230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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: 02.206.226
• Device Catalogue Number: 02.206.226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/08/2018
• 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: 46