MAUDE Adverse Event Report: ARTHREX, INC. SCRWDRV,CANN FOR BIO INT. SCRW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCRWDRV,CANN FOR BIO INT. SCRW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
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 requested/is expected but has not returned for evaluation.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 that during a anterior cruciate ligament surgery, when screwing the femoral screw, the screwdriver broke.1 fragment remained in the femoral screw and it is not possible to remove it.The surgery was finished successfully with the same device which was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update 10th.Jan.2019: the broken piece is set up inside the screw, well implanted into the bone.
Additional Manufacturer Narrative
The complaint is confirmed.The distal hex drive feature broke off from the shaft at its base.The fracture face appears to show a mix of bending and torsion stresses, such that can be caused by prying and/or leveraging while torquing the device.

• Brand Name: SCRWDRV,CANN FOR BIO INT. SCRW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8288790
• Report Number: 1220246-2019-00870
• Device Sequence Number: 13931300
• Product Code: LXH
• UDI-Device Identifier: 00888867015425
• UDI-Public: 00888867015425
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/01/2019

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,CANN FOR BIO INT. SCRW
• Device Catalogue Number: AR-1386
• Device Lot Number: 535803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other