MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW W/DISP SHTH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
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 portion of the device not left in the patient was reported to have been discarded.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 an acl reconstruction procedure, upon inserting a quantity three ar-1370c (lot: 10284684 // qty.2 & lot: 10292589 // qty.1) into the femur, approximately 7 mm of the screw would go in and then break.The rep stated the 7 mm portion of the screws that were in the bone tunnel remained implanted and the broken heads of the screws were retrieved.The graft deemed adequate fixation and the case was completed.However, the rep stated the rehab will be slower based on the fixation only being adequate and not normal or ideal.A dilator was used to prep the bone for the first screw, and a tap was used for the other two screws.The bone quality was hard.The retrieved screw heads were discarded and will not be returning for evaluation.Additional information received on 08/26/2019: the sales rep reported to the arthrex product manager that the patient had particularly hard bone and the surgeon did not tap the bone as they normally would in this case.The graft ended up well-fixed, albeit by a shorter piece of screw, and the surgeon stated to the rep that they should have tapped the bone.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8961318
• Report Number: 1220246-2019-01295
• Device Sequence Number: 2042407
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 02/28/2021
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1370C
• Device Lot Number: 10284684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/04/2019
• 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