MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE TRANSFIX 5 X 50MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPOSITE TRANSFIX 5 X 50MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2020
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 during surgery when hitting in, about half of the implant broke into many pieces.The rest of broken screw was left in patient.Update 22-dec-2020: the broken part of screw has not been removed from patient, because it would have been necessary to drill it out.But the broken screw doesn¿t fulfill its function.The other broken pieces of the screw were all flushed out.Initially it was planned a transfix technique, which fixes from the lateral side.Due to the breakage it was changed to fix it through the anteromedial portal, which has an effect on the tearing forces.An ar-4030c-08 was used to finish the surgery successfully.A second surgery was not necessary.

• Brand Name: BIO-COMPOSITE TRANSFIX 5 X 50MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11120065
• Report Number: 1220246-2021-02453
• Device Sequence Number: 13632190
• Product Code: MAI
• UDI-Device Identifier: 00888867013704
• UDI-Public: 00888867013704
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: 02/28/2022
• Device Model Number: BIO-COMPOSITE TRANSFIX 5 X 50MM
• Device Catalogue Number: AR-1351C-02
• Device Lot Number: 10704929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other