MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS IMPLANT SET; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number FIBERTAK BICEPS IMPLANT SET

Device Problems Break (1069); Device Slipped (1584); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2020

Event Type  Injury  

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 Description

It was reported while using the drill within the (b)(4) fibertak biceps implant set, the drill became stuck in the guide.The rep reported the drill guide seemed to have had a metal bur that caused the drill to seize up and subsequently snap off in the drill guide.A second (b)(4) from the same lot was opened to use the drill guide for anchor insertion, and the anchor pulled right back out.The rep stated they suspect that the hole drilled was enlarged from the problem during the drilling, and this is why the anchor pulled out.A 3.5 swivelock was placed in the same hole and pulled out as well.Surgeon went on and created a bony tunnel with suture to finish the case.The sales rep reported there was no adverse event involved.Additional information received on 01/03/2020: the procedure taking place was an mpfl, and the bone quality was hard.The drill broke off in the drill guide, and no debris were produced.An unplanned incision was not necessary.It was reported that a total of two fibertaks (within the two complaint (b)(4)implant sets), one (b)(4) suturetak, and one (b)(4) swivelock all pulled out during the surgery.The suturetak and swivelock were pulled from the facility's inventory.The surgeon resorted to a bone tunnel to complete the procedure.All components of the two (b)(4), and all implants were discarded and will not be returning for evaluation.The rep reported a possible factor as to why the anchors all pulled out is that the patient had an ocd repair at the same time done in the same area as the anchors were placed.The surgeon was not surprised at the anchors pulling out as much as the fact that the drill seized in the drill guide.

• Brand Name: FIBERTAK BICEPS IMPLANT SET
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9607419
• MDR Text Key: 176069776
• Report Number: 1220246-2020-01586
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867305427
• UDI-Public: 00888867305427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2020

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
• Device Operator: Health Professional
• Device Model Number: FIBERTAK BICEPS IMPLANT SET
• Device Catalogue Number: AR-3670
• Device Lot Number: 10380434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other