MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, BICEPS TENODESIS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPLANT SYSTEM, BICEPS TENODESIS
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	09/24/2020
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 during a biceps tenodesis procedure the ar-1662s-1 implant system was being used.Upon using the reamer to drill the humeral head the device was not drilling efficiently, and the surgeon had to apply more pressure than usual to create the socket.Once the reamer finally started puncturing the bone and drilling, the surgeon had difficulty stopping the device fast enough.The patient came back to the surgeon a short time after the surgery complaining of pain at the surgical site.X-rays were taken and it was discovered that the reamer had drilled all the way through the cortex.The patient had to undergo a second surgery in which non arthrex plate and screws were implanted to fix the issue.Additional information obtained 10/1/2020: the original surgery date was (b)(6) 2020.The patient was seen for a follow up on (b)(6) 2020 due to pain in shoulder.An x-ray revealed a fracture on the posterior cortex.The patient was taken back to surgery on (b)(6) 2020 and a plate and screw was used to reduce an stabilize the fracture and the 5.5 swivelock was removed from the patient.

• Brand Name: IMPLANT SYSTEM, BICEPS TENODESIS
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10698344
• Report Number: 1220246-2020-02237
• Device Sequence Number: 19597645
• Product Code: MAI
• UDI-Device Identifier: 00888867096028
• UDI-Public: 00888867096028
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 10/19/2020

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: 04/30/2025
• Device Model Number: IMPLANT SYSTEM, BICEPS TENODESIS
• Device Catalogue Number: AR-1662S-1
• Device Lot Number: 10934473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other