MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDLOCK HIP KNOTLESS FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	23-2001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy, on insertion the dial to take up and tension the suture would not turn, the suture could not be taken up and the internal wire could be seen as twisted/jammed inside.An additional bone hole was drilled to use the back up device.The procedure was completed with a back up device, with no significant delay or patient injuries.
Additional Manufacturer Narrative
Company representative added.The returned implant, intended for use in treatment, was returned as an mdr and returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection of the returned implant for a speedlock hip knotless fixation device shows no manufacturing abnormalities.The implant is not detached.The snare line is reeled through the wheel and broken; no sutures attached.The suture ratchet knob and the dial could be turned and the implant could be detached.The complaint was verified, but the root cause could not be determined with certainty.Probably root cause are (1) improper suture loading.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use provided with the device associated with set-up and use of the device such as (2) do not over-tension the suture -failure to distribute proper tension through both suture ends may result in inadequate suture lock and potential failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SPEEDLOCK HIP KNOTLESS FIXATION DEVICE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8906758
• Report Number: 3006524618-2019-00405
• Device Sequence Number: 2730902
• Product Code: MBI
• UDI-Device Identifier: 00817470003413
• UDI-Public: 00817470003413
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123240
• 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): 09/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 23-2001
• Device Lot Number: 2006047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1