MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED 1/ 1.3 SUTURETAP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	AR-3602-2
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device reported to have been discarded.
Event or Problem Description
It was reported that three fibertak double loaded w/ 1.3 suture tape were used in a bony bankhart repair case.Upon completing of the case, a c-arm was brought in to check the reduction under fluoroscopy and found a metal fragment embedded in the glenoid.After checking all instruments, the end of one of the fibertak drivers was found to be missing the tip.Additional information received 7/3/2017: the surgeon does not plan on a second surgery to remove the un-retrieved fragment.The devices were disposed of after the case.

• Brand Name: FIBERTAK DOUBLE LOADED 1/ 1.3 SUTURETAP
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6692667
• Report Number: 1220246-2017-00241
• Device Sequence Number: 13661072
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: 00888867206953
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151230
• 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): 07/07/2017

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: 01/01/2022
• Device Catalogue Number: AR-3602-2
• Device Lot Number: 10122169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/07/2017
• 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