MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/60MM; SCREW,FIXATION,BONE

Model Number	02.127.160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: additional device product codes: (b)(4).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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 an unknown date, the patient underwent a screw removal due to pain.There were three (3) variable angle (va) locking screws that were removed.The implanted screws were too long, which caused pain to the patient.Concomitant device reported: plate (part number unknown, lot unknown, quantity 1), screw (part number unknown, lot unknown, quantity unknown), 3.5mm variable angle locking screw/slf-tpng/strdrv/70mm (part number 02.127.170, lot unknown, quantity 1), 3.5mm variable angle locking screw/slf-tpng/strdrv/75mm (part number 02.127.175, lot unknown, quantity 1).This report involves one (1) 3.5mm variable angle locking screw/slf-tpng/strdrv/60mm.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/60MM
• 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: 10128093
• Report Number: 2939274-2020-02693
• Device Sequence Number: 19684794
• Product Code: HWC
• UDI-Device Identifier: 10886982043344
• UDI-Public: (01)10886982043344
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: 02.127.160
• Device Catalogue Number: 02.127.160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM VARIABLE ANGLE LOCKING SCREW 70MM; 3.5MM VARIABLE ANGLE LOCKING SCREW 75MM; UNK - PLATES; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention