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

Model Number OM-6500

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a shoulder arthroscopy, while the doctor was deploying the speedscrew and tensioning each side, when after reducing the left side, he went to slide the mechanism to the right but it would not slide.He tried pushing harder but it would not budge.He was concerned that it may break so he tensioned and locked the left side off and opened a new speedscrew anchor to take the other tape that could not be deployed in the original anchor.The procedure was completed with a back up device that was used in a second bone hole, with no significant delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.A dhr/batch record review for lot 2029780 finding no discrepancies from released and operating procedures nor conditions that could contribute to the event.The review of the complaint history for the associated complaint product found no similar events in the last three years for the involved lot.Without the reported product a fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.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) incorrect suture loading (2) inadequate tensioning applied to cuff.No containment or corrective actions are recommended at this time.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: 9446985
• MDR Text Key: 177945961
• Report Number: 3006524618-2019-00591
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Device Lot Number: 2029780
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1