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	Foreign Body In Patient (2687)
Date of Event	01/30/2020
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 hip labral repair procedure, when the surgeon was impacting the ar-3602h, the anchor bent.The case was completed with no further issues.During the followup visit it was found that a piece of the impactor had broken off.Additional information obtained 5/5/2020: during the follow up visit an x-ray was taken and the metallic fragment was visualized on x-ray.The surgeon does not have plans for a second surgery.The impactor was examined after the surgery however it was not suspected that anything had broken off at the time of procedure and therefore it was not examined thoroughly for breakage.The anchor was taken from facility inventory.Additional information obtained 5/7/2020: the bent anchor was left in the patient and was used to complete the procedure.

• 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: 10096488
• Report Number: 1220246-2020-01853
• Device Sequence Number: 3406090
• Product Code: MBI
• UDI-Device Identifier: 00888867295520
• UDI-Public: 00888867295520
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/28/2020

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 Expiration Date: 05/31/2023
• Device Model Number: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Device Catalogue Number: AR-3602H
• Device Lot Number: S706297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/28/2020
• 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