MAUDE Adverse Event Report: ARTHROCARE CORP. OPUS SPEEDSCREW IMPLANT; SCREW, FIXATION, BONE

Model Number	74024626
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the surgeon attempted to insert the speedscrew; however, the suture would not wind through the internal ratchet.There was a backup device available, which was used in the originally drilled bone hole.It is unknown if there was a surgical delay.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.The reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device 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 a isolated issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found - preoperative and operating procedures including knowledge of surgical techniques and proper selection and placement of the implant are important considerations in the successful utilization of this system.- do not load the suture into the implant prior to insertion into bone.- ensure that the suture does not wrap around the inserter while screwing the implant into bone.- do not cross suture limbs inferior to the inserter shaft prior to inserting into suture eyelet.Do not over tension the suture.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) incorrect alignment during or after insertion.(2) excessive torque (3) inadequate tension distribution applied to cuff.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: OPUS SPEEDSCREW IMPLANT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10605975
• Report Number: 3006524618-2020-00838
• Device Sequence Number: 11050863
• Product Code: HWC
• UDI-Device Identifier: 03596010554475
• UDI-Public: 03596010554475
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 02/16/2023
• Device Model Number: 74024626
• Device Catalogue Number: OM-6500
• Device Lot Number: 2051220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: Other; Required Intervention