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

Catalog Number	23-2001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip procedure, the device snare broke under no tension upon winding.The surgeon started winding and reducing the suture in the device, and then the implant made a cracking sound and broke.A backup device was available to complete the procedure with no patient injuries.It is unknown if there was a delay in the procedure.
Event or Problem Description
It was reported that during a hip procedure, the device snare broke under no tension upon winding.The surgeon started winding and reducing the suture in the device, and then the implant suture made a cracking sound and broke.Additional information confirm that the anchor did not broke and was left inside the patient.Additional bone holes were required in order to complete the procedure with another backup device with no significant delay.
Additional Manufacturer Narrative
He reported speedlock hip knotless fixation 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 and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during a hip procedure, the device snare broke under no tension upon winding.The surgeon started winding and reducing the suture in the device, and then the implant suture made a cracking sound and broke.Additional bone holes were required in order to complete the procedure.¿ an exact root cause cannot be determined without evaluation of the device.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: 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: 8362277
• Report Number: 3006524618-2019-00106
• Device Sequence Number: 19165630
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2019

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: 09/07/2020
• Device Catalogue Number: 23-2001
• Device Lot Number: 2006243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/28/2019; 04/18/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/01/2019; 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1