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

Catalog Number	23-2001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy, when the doctor was going to mallet in the anchor, the inserter and the anchor snapped off, the anchor was not able to be used, the device broke into two pieces and broken pieces were removed using an arthroscopic grasper.The procedure was completed with a back up device with no delay or patient injury reported.
Additional Manufacturer Narrative
The reported 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 fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during a hip arthroscopy, when the doctor was going to mallet in the anchor, the inserter and the anchor snapped off, the anchor was not able to be used, the device broke into two pieces and broken pieces were removed using an arthroscopic grasper.¿ 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: misalignment of implant and inserter excessive force.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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: 9150301
• Report Number: 3006524618-2019-00497
• Device Sequence Number: 19629692
• 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
• Report Date (Section B): 11/07/2019

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: 05/12/2021
• Device Catalogue Number: 23-2001
• Device Lot Number: 2014581
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1