MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW, FIXATION, BONE

Model Number	02.211.018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patients weight is not provided for reporting.Date of postoperative screw breakage is unknown.Additional device product code: hrs.Implanted in june 2017; exact date is unknown.Part of the screw remained in the patient¿s bone; device not considered explanted.Complainant part 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 in (b)(6) 2017 the surgeon performed a metatarsophalangeal fusion on the patient.Post-op, in (b)(6) 2018, the patient complained of pain at the operation site.The patient states that the site had been run over by a person in a wheelchair.X-rays showed two broken screws and a plate loosening.During a scheduled revision surgery on (b)(6) 2018, the surgeon removed the plate and screws.The surgeon did not remove the pieces of the broken screws from the patient and they were left in the patient¿s foot.The fusion site was refused with two staples.The patient outcome was good with no surgery delay.Procedure was completed successfully.Concomitant devices reported: 2.7mm va locking screw 18mm (part 02.211.018, lot unknown, qty 1), 2.7mm va locking screw 16mm (part 02.211.016, lot unknown, qty 1), 2.7mm va locking screw 14mm (part 02.211.014, lot unknown, qty 1), 2.7mm cortex screw (part 202.820, lot unknown, qty 2), 2.4/2.7 va-lcp forefoot/midfoot plating system (part 02.211.237, lot 6613277, qty 1).This is report 2 of 2 for complaint (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• 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: 7384753
• Report Number: 2939274-2018-51342
• Device Sequence Number: 13710815
• Product Code: HWC
• UDI-Device Identifier: 10886982053602
• UDI-Public: (01)10886982053602(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• 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): 03/02/2018

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: 02.211.018
• Device Catalogue Number: 02.211.018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/30/2018
• 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: 48 YR