MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS INSTRUMENT SET; BIT, DRILL

Model Number	FIBERTAK BICEPS INSTRUMENT SET
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
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 the disposable drill within the ar-3671ds, fibertak biceps instrument set cold fused with the disposable guide.The guide was placed into sub pec in the prox humerus, and when the drill was inserted into guide the drill fused with the guide.The drill and guide were intact when removed.The sales rep reported there was no harm to that patient.Additional information obtained 6/4/2020: the procedure was a bicep tenodesis.When the drill fused with the guide the sales rep opened another drill with guide.The surgeon drilled again and it made the tunnel too big and the anchor pulled out.The doctor decided not to repair.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection showed that the drill was stuck inside the drill guide.Some blue debris could visually be seen in the open slot of the drill guide (image 2).The drill showed no visible signs of damage aside from being stuck inside of the drill guide.The tip of the drill bit measured as meeting the drawing (0.0745" outer diameter).The inner diameter of the drill guide was unable to be measured as the drill bit was stuck inside of the drill guide.Most likely cause of this failure is leveraging and/or angling of the drill or drill guide while the drill is inside of the drill guide.

• Brand Name: FIBERTAK BICEPS INSTRUMENT SET
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10184980
• Report Number: 1220246-2020-01918
• Device Sequence Number: 19515339
• Product Code: HTW
• UDI-Device Identifier: 00888867305410
• UDI-Public: 00888867305410
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 12/31/2024
• Device Model Number: FIBERTAK BICEPS INSTRUMENT SET
• Device Catalogue Number: AR-3671DS
• Device Lot Number: 10555433
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 250