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

Model Number OM-6500

Device Problem Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during the primary rotator cuff repair surgery, when initially removing slack from the sutures with the speedscrew device, one suture failed to advance.Likely a snare issue.The incident occurred inside the patient and the sutures were released with a knife and the anchor was unscrewed out of bone.A backup device was used in the same bone hole and no significant delay or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, 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 event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found 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: incorrect alignment during or after insertion.Excessive torque or 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10991209
• MDR Text Key: 220901834
• Report Number: 3006524618-2020-01087
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00817470005196
• UDI-Public: 00817470005196
• Combination Product (y/n): N
• PMA/PMN Number: K081893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Device Lot Number: 2053246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention