MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRUCIFORM SCREWDRIVER

Model Number	313.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used in a veterinary case - no patient information will be reported.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, while the surgeon was performing a 2.4 tibial-plateau-leveling osteotomy (tplo) and tightening a cortex screw, the tip of the cruciform screwdriver sheared off the driver.There were fragments generated from the broken device and were removed easily without additional intervention.There was a surgical delay reported with an unknown number of minutes.The procedure was completed successfully using an unknown periosteal elevator.Patient outcome is unknown.Concomitant device: unknown cortex screw (part# unknown, lot# unknown, quantity unknown), unknown tplo plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) cruciform screwdriver.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).A review of the device history record.Device history lot: part: 313.960; lot: 1940152; manufacturing site: (b)(4); release to warehouse date: 07.July 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary background: veterinary complaint: it was reported that on an unknown date, while the surgeon was performing a 2.4 tibial-plateau-leveling osteotomy (tplo) and tightening a cortex screw, the tip of the cruciform screwdriver sheared off the driver.There were fragments generated from the broken device and were removed easily without additional intervention.There was a surgical delay reported with an unknown number of minutes.The procedure was completed successfully using an unknown periosteal elevator.Patient outcome is unknown.Concomitant device reported: unknown cortex screw ( part# unknown, lot# unknown, quantity unknown) and unknown tplo plate ( part# unknown, lot# unknown, quantity 1) this complaint involves one (1) device.Investigation flow: damage.Visual inspection: cruciform screwdriver was received at us (b)(4).Upon visual inspection at (b)(4), it is observed that distal tip of the device was broken.The broken fragments were not received at us cq.The rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.No design issues were found which can contribute to this complaint condition.Investigation conclusion: a visual inspection, dimensional inspection, and document/specification review were performed as part of this investigation.The complaint is being confirmed as the distal tip of the device was broken.While a definitive root cause could not be determined for the reported problem, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, no corrective and/or preventative action is proposed.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.

• Brand Name: CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9238274
• Report Number: 2939274-2019-61745
• Device Sequence Number: 2409169
• Product Code: HXX
• UDI-Device Identifier: 10887587037189
• UDI-Public: (01)10887587037189
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 10/08/2019

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: 313.96
• Device Catalogue Number: 313.96
• Device Lot Number: 1940152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1