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

Catalog Number	23-2001
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that almost a year and a half after a right hip arthroscopy labral repair/cam debridement the patient began experiencing pain.No incidents or traumatic episodes were reported in this period of time.After an mri, a hip arthroscopy was performed, at this point the lateral anchor was found detached from the rim of the acetabulum and hanging by a thread.The device was retrieved and labral debridement was performed.
Additional Manufacturer Narrative
The returned implant, intended for use in treatment, was declared 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 detached with implemented broken sutures; the device itself was not returned with the implant; the complaint was verified but the root cause could not be determined with certainty as the part was loosening from the rim of the acetabulum.Potential root causes could be, bone quality or incomplete insertion.There are no manufacturing abnormalities visually observed with the returned device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.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.(1) do not implant the anchor in poor quality bone or where bone quantity is limited.(2) incomplete insertion or poor bone quality may result in anchor pullout.
Event or Problem Description
It was reported that almost a year and a half after a right hip arthroscopy labral repair/cam debridement the patient began experiencing pain.No incidents or traumatic episodes were reported in this period of time.After an mri a hip arthroscopy was performed, at this point the lateral anchor was found detached from the rim of the acetabulum and hanging by a thread.The device was retrieved and labral debridement was performed.Patient's evolution is as expected after the revision surgery.

• 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: 8847363
• Report Number: 3006524618-2019-00363
• Device Sequence Number: 2716498
• Product Code: MBI
• UDI-Device Identifier: 00817470003413
• UDI-Public: 00817470003413
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 23-2001
• Device Lot Number: 1162633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR