MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Catalog Number	313.930
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 313.930, lot no.: 8831123: manufacturing location: (b)(4), release to warehouse date: 01.Apr.2014: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed.It was reported that the hexagonal screwdriver is defective.This complaint is confirmed.The device was received at customer quality (cq) with a worn distal hex tip.The hex point/edges are worn/rounded/stripped.Whether this complaint can be replicated at customer quality (cq) with a functional test is not applicable for this complaint condition.No new malfunctions were identified as a result of the investigation.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Screwdriver assembly drawing and shaft component drawing for the device were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.A dimensional inspection was not performed because the damage/wear was visually confirmed on the returned 3+ year old reusable screwdriver.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 patient had revision surgery on (b)(6) 2017 for scar revision and hardware removal due to painful hardware.Unknown which hardware was painful.The surgeon had difficulty removing the screws with both screwdrivers.The screwdrivers were noted to have rounded tips.Another set of screwdrivers were used to successfully remove the screws.There were no issues with the hardware.Patient had healed and requested that the painful hardware be removed.During the scar revision, the surgeon dissected an inch-wide scar on the lateral knee and sutured it back together to reduce the size of the scar.There was no surgical delay.Routine x-rays were taken as standard for the procedure.The procedure was completed successfully.During manufacturer investigation process of the returned hexagonal screwdriver, it was identified the hex point/edges are worn/rounded/stripped.This condition was reevaluated and determined to be reportable on (b)(6) 2018.This report addresses the screwdrivers with rounded tips.Difficulty removing screws.Removal of the painful hardware (plate and screws) has been captured under linked complaint (b)(4).Concomitant devices reported: 5.0mm cannulated screws (part # unknown, lot # unknown, quantity approximately 5).This is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.0MM 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: 7293381
• Report Number: 2939274-2018-50761
• Device Sequence Number: 1249900
• Product Code: HXX
• UDI-Device Identifier: 10886982188243
• UDI-Public: (01)10886982188243(10)8831123
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/28/2017

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: 313.930
• Device Lot Number: 8831123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1