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

Catalog Number OM-6500

Device Problems Crack (1135); Entrapment of Device (1212); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that when deploying the second speedscrew anchor (lateral row), a mechanism made a crack while individually tensioning a suture limb.The black tab was then moved into the final position to advance the internal suture lock and remove the anchor inserter however the top end was jammed and could no longer rotate, meaning the inserter was stuck and could not be removed from the anchor.Unable to remove the inserter the surgeon unscrewed the anchor and found the suture had cut.Snares appear to be intact.No patient injury reported.

Manufacturer Narrative

The reported speedscrew implant device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿the inserter was stuck and could not be removed from the anchor.Unable to remove the inserter the surgeon unscrewed the anchor and found the suture had cut.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) using the incorrect suture, (2) excessively tensioning, (3) inadequate tensioning applied to cuff.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8075553
• MDR Text Key: 127408719
• Report Number: 3006524618-2018-00601
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: OM-6500
• Device Lot Number: 1174537
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1