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	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2019
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 just received and has not yet been evaluated.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported upon inserting the distal screw for the graft during a pcl procedure, a quantity of three ar-1995shn, noncannulated short screwdriver shaft tips twisted.The three drivers were all from lot: 10193571.The facility reporter stated that the tip of the third ar-1995shn broke off into the head of the screw (part number unknown).The broken driver tip was flush with the head of the screw and remains implanted in the patient.The facility reporter stated that there were no attempts made to remove the screw as the screw was fully purchased and implanted.The case was completed without further incident.
Additional Manufacturer Narrative
Complaint confirmed.All three devices were found to be twisted, with one of them missing the distal end of the drive feature.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: 8500582
• Report Number: 1220246-2019-01024
• Device Sequence Number: 1870877
• Product Code: LXH
• UDI-Device Identifier: 00888867025684
• UDI-Public: 00888867025684
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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
• Device Lot Number: 10193571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other