MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Model Number	314.27
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: investigation flow: visual.Visual inspection: the large hexagonal screwdriver (p/n 314.27 lot unk) was received showing the hex distal driver tip stripped and rounded and discolored and worn phenolic le grade handle.The discolored handle and stripped driver tip are potential end of life indicators for the instrument from normal wear and reprocessing over the part¿s lifetime.Conclusion: after a visual inspection per guidance provided in windchill document # (b)(4), it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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) 2020, the large hexagonal screwdriver got stuck into the screw heads while fixing a humeral shaft fracture with a narrow locking compression plate (lcp) plate.This was due to wear and tear on the screwdriver shaft due to frequent use of the set.Another screwdriver was used to complete the procedure.There was no surgical delay.The procedure was successfully completed.There was no patient harm.Concomitant device reported: unknown cortex screw (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

• Brand Name: LARGE HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9843517
• Report Number: 2939274-2020-01312
• Device Sequence Number: 16851439
• Product Code: HXX
• UDI-Device Identifier: 10886982188731
• UDI-Public: (01)10886982188731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: OTHER
• 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): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 314.27
• Device Catalogue Number: 314.27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 80