MAUDE Adverse Event Report: ARTHREX, INC. HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a (b)(6) 2020 hip arthroscopy/labral repair procedure four ar-3602h, hip fibertak suture anchors (lot 10298673), were used.One of the inserter tips (approximately 1.5 - 2 cm) broke off and was embedded in the patient's bone.Fragment was unable to be retrieved.Sales representative who was present reports the surgeon did not use excessive force to implant the device and followed the instructions from the technique guide.

• Brand Name: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10562574
• Report Number: 1220246-2020-02187
• Device Sequence Number: 2823134
• Product Code: MBI
• UDI-Device Identifier: 00888867295520
• UDI-Public: 00888867295520
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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 Model Number: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Device Catalogue Number: AR-3602H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/21/2020
• 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: Other