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

Model Number	23-2001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the speedlock hip implant broke.The incident occurred before the procedure, no complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, intended to be used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.Visual inspection of the device shows no manufacturing abnormalities.The device was deployed.The anchor at distal end is partial broken with attached broken/frayed sutures.The device is intended for single use and could not be functional tested.An attempt was made to test the basic functions.The other end of the suture was tightened and reeled through the wheel; the suture ratchet knob could be slightly rotated in both directions until stop; further functional tests were not doable.The complaint was confirmed.Factors that could have contributed to the reported event include: misalignment of implant and inserter bone thickness.Over tensioning the suture.
Additional Manufacturer Narrative
The device reported, intended to be used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.No product identification information was provided, thus a manufacturing record review could not be conducted.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force.No containment or corrective actions are recommended at this time.

• 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: 10182136
• Report Number: 3006524618-2020-00398
• Device Sequence Number: 2741368
• Product Code: MBI
• UDI-Device Identifier: 00817470003413
• UDI-Public: 00817470003413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2020

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 Model Number: 23-2001
• Device Catalogue Number: 23-2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 10/09/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/05/2020; 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1