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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/02/2020
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
An arthrex employee has reported that during an anterior cruciate ligament surgery with transfix pin, while hammering in the pin, the head was torn and split into 2 halves.The surgeon was not able to retrieve the part out of the patient and had to switch to a different technique.The surgeon used a screw to finish the surgery successfully.

• 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: 10546363
• Report Number: 1220246-2020-02175
• Device Sequence Number: 3033162
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: 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: 09/03/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other