MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT FOR 1.5MM HCS T4; SCREWDRIVERS

Catalog Number	03.230.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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, patient underwent a hardware removal surgery.During the surgery, a stardrive screwdriver shaft broke off in the screw head while attempting to remove a headless compression screw that had backed out into the knee joint.The screw was originally implanted several years ago.The surgeon had to remove the screw by drilling over it.This caused an unknown length of surgical delay and more x-rays had to be taken.Patient and procedure outcomes were unknown.(b)(4) will capture the intra-operative events, where the stardrive screwdriver shaft broke.(b)(4) will capture the post-operative events, where an implant was found out to have backed out.Concomitant device reported: 1.5mm headless compression screw: (part# unknown, lot# unknown, qty# 1).This report is for one (1) stardrive screwdriver shaft for 1.5mm hcs t4.This is report 1 of 2 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT FOR 1.5MM HCS T4
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7842012
• Report Number: 2939274-2018-53581
• Device Sequence Number: 16629387
• Product Code: HXX
• UDI-Device Identifier: 10886982077271
• UDI-Public: (01)10886982077271
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/15/2018

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 Catalogue Number: 03.230.004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/04/2018
• 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: 19 YR