MAUDE Adverse Event Report: ARTHREX, INC. SCRWDRV SFT,SHT NON-CANN,2.5MM HEX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an operation to remove a screw that was implanted 10 years ago.The surgeon was using hex non-cannulated screwdriver, ar-1995shn.As the surgeon turned the driver, the tip of the driver became damaged and broke off inside the head of the screw.The tip was unable to be retrieved and the surgeon ended the operation.No further details.Additional information has been requested.Additional information provided on 10/3/2018: the surgery was aborted and the screw was left in.The reporter has no information as to if or when the surgery will be scheduled.
Additional Manufacturer Narrative
The complaint was confirmed for twist and broken tip.Examination confirms a torsion fracture.The most likely cause(s) of this type of event include continually applying torque when the implant is not properly aligned, leveraging, or torquing while leveraging the device.

• Brand Name: SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7994480
• Report Number: 1220246-2018-00710
• Device Sequence Number: 18882748
• Product Code: LXH
• UDI-Device Identifier: 00888867025684
• UDI-Public: 00888867025684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
• Device Catalogue Number: AR-1995SHN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other