MAUDE Adverse Event Report: ARTHREX INC. BIO-TRANSFIX EXTRACTION PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1973E
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.No device malfunction identified.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a case, as the surgeon was attempting hardware removal using the acl revision kit, the tip of the bio-trans fix extractor broke while trying to remove another manufacturer's cross pin product.The tip of the extractor was not retrieved.Follow-up investigation: the case was an acl revision the tip was not removed and no x ray was taken.Because the femoral cross pin could not be removed, the surgeon did an over the top acl instead of the planned technique.

• Brand Name: BIO-TRANSFIX EXTRACTION PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7365028
• Report Number: 1220246-2018-00095
• Device Sequence Number: 11071580
• Product Code: LXH
• UDI-Device Identifier: 00888867024656
• UDI-Public: 00888867024656
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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 Catalogue Number: AR-1973E
• Device Lot Number: 02072300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/23/2018
• 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