MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	BIO-COMP INTER-FERENCE SCRW
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/12/2020
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 patient developed an inflammation in the tibia in the are of the implant socket after an acl re-construction, and meniscus re-construction.No information received when device was implanted.

• Brand Name: BIO-COMP INTER-FERENCE SCRW
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10764225
• Report Number: 1220246-2020-02295
• Device Sequence Number: 11783938
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 01/31/2021
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 10277716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other