MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING; SCREWDRIVERS

Catalog Number	03.114.002
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient 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.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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 report that on (b)(6) 2017, patient underwent implant surgery for treatment of a (orif) open reduction internal fixation to the right fourth metacarpal bone due to a bone fracture where the surgeon was using the 1.5 mm (lcp)locking compression system.During the produce, surgeon chose to use one (1) 1.5 mm lcp t-plate and three (3) 1.5 mm cortex self tapping screws.Surgeon originally wanted to use a condylar plate for the fracture reduction, but this plate was unavailable in the lcp set.(due to this plate was used during a surgery the day before.) surgeon cut and contoured the t-plate to the appropriate length and attempted to insert three (3) cortex screws.Surgeon struggled with three (3) different screwdrivers when attempting to implant each of the three (3) cortex screws.All three screwdrivers became stripped and would no longer retain the screws.Additional screwdrivers were available in the operating room to continue the surgery.At this point in the procedure, surgeon removed the previously implanted three cortex screws and plate.Patient was ultimately implanted with two (2) 1.5 mm cortex screws and fiber wire sutures to compress the bone fracture.Surgery was completed successfully with a 45-minute time delay.Patient was reported in stable condition.Concomitant devices reported: 1.5 mm cortex screws slf-tpng with t4 stardrive recess 10 mm (part# 02.214.110, lot# unknown, quantity 2) 1.5 mm cortex screws slf-tpng with t4 stardrive recess 12 mm (part# 02.214.112, lot# unknown, quantity 1).This report is for one (1) stardrive screwdriver shaft t4/42 mm/self-retaining.This is report 2 of 4 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7096174
• Report Number: 1719045-2017-50013
• Device Sequence Number: 16369608
• Product Code: HXX
• UDI-Device Identifier: 10886982072993
• UDI-Public: (01)10886982072993(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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 Catalogue Number: 03.114.002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR