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

Model Number	OM-8500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff repair, the implant severed the suture and the suture got stuck inside the insertion device, no additional bone hole was required to complete the surgery.No delay or other complication were reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h3, h6.The reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that excessive force can result in device damage.A review of product print/specifications found that there were no abnormalities observed.Visual evaluation shows device is deployed, the anchor is broken and attached to the plug.No manufacturing abnormalities were observed.The device is intended for single use and can not be tested.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) incorrect suture loading (2) over tensioning the suture.(3) incorrect activation knob position.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H10: additional information in b5.
Event or Problem Description
It was reported that during a rotator cuff repair, the implant of the speedscrew severed the suture and the suture got stuck inside the insertion device when it was being used.The initial anchor was left inside the patient's anatomy.No delay or other complication were reported.Smith and nephew back-up device was used in an additional bone hole to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 10597434
• Report Number: 3006524618-2020-00823
• Device Sequence Number: 18925528
• Product Code: HWC
• UDI-Device Identifier: 00817470004076
• UDI-Public: 00817470004076
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: OM-8500
• Device Catalogue Number: OM-8500
• Device Lot Number: 2030035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/25/2020; 09/25/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/02/2020; 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention