MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BALL HEX SCREWDRIVER 8MM; SCREWDRIVERS

Model Number	03.010.092
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part: 03.010.092, lot: 9724351, manufacturing site: (b)(4), release to warehouse date: 01.Dec.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: the ball hex screwdriver (part # 03.010.092, lot # 9724351, mfg # 01-dec-2015) was received at us cq with the distal ball tip of the screwdriver broken.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed, the outer diameter of the shaft, measured and is within specification per relevant drawing.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 on (b)(6) 2019, during an unknown surgery, a ball hex screwdrivers broke when trying to get the connecting screw out.Connecting screw connects insertion handle to the lateral entry tibial nail.During procedure connecting screw would not come out of the nail.It was extremely tight and broke the ball hex screwdriver and bent the connecting screw.There were no fragments left in patient.Finally, it was able to get it out with a back up device.Procedure was completed with twenty (20) minutes surgical delay.Patient was not affected.This report is for one (1) ball hex screwdriver 8mm.This is report 1 of 3 for (b)(4).

• Brand Name: BALL HEX SCREWDRIVER 8MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8926519
• Report Number: 2939274-2019-60038
• Device Sequence Number: 11257273
• Product Code: HXX
• UDI-Device Identifier: 10886982067630
• UDI-Public: (01)10886982067630
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/26/2019

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 Model Number: 03.010.092
• Device Catalogue Number: 03.010.092
• Device Lot Number: 9724351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR