MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDSCREW 6.5MM; SCREW, FIXATION, BONE

Model Number	OM-8500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when passing the suture the puller broke (the metal wire that feeds the suture).The physician double-stacked a 6.5 on top of a 5.5, all the pieces were removed from the patient.No patient injury was reported.
Additional Manufacturer Narrative
The reported speedscrew device, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was not established based on our visual observations.Visual evaluation of the returned device shows the device was received undeployed.Approximately 2 inches of arthrex suture were found snared and partially reeled in the shaft.The suture was reeled in by the inspector and the suture snare lines and loops were found intact.Clinical suture on the green snare line was found shredded.No visual discrepancies were found with the returned device therefore customers complaint was not confirmed.The device was received in acceptable condition; however, the clinical suture was found damaged.The instructions for use contraindicate the use of suture other than the approved magnumwire suture.No visual discrepancies were observed with the device; however, the wrong suture was used with the returned device and may have contributed to device failure.The instruction for use (ifu) were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SPEEDSCREW 6.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7337043
• Report Number: 3006524618-2018-00120
• Device Sequence Number: 16324521
• Product Code: HWC
• UDI-Device Identifier: 00817470004076
• UDI-Public: (01)00817470004076(17)181031(10)1123293
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: OM-8500
• Device Catalogue Number: OM-8500
• Device Lot Number: 1123293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/25/2018; 05/23/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/23/2018; 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR