MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, FASTAK, SMALL BONE; SCREW, FIXATION, BONE

Catalog Number	AR-1322-752SF
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2017
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 device was requested for evaluation but was not returned 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.The most likely cause(s) of this type of event include over-insertion, not inserting the implant coaxial to the bone tunnel, or prying/leveraging the driver while the implant is still loaded.This is the (b)(4) 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 requested but not yet received.
Event or Problem Description
It was reported that during an atfl repair procedure, the driver shaft on the small bone fastak¿ suture anchor with 2-0 fiberwire broke as the anchor was being seated into the bone.All metal fragments were removed from the patient and the tip of the driver was removed from the anchor, however, the broken anchor had to be left in.The surgeon was able to trim the anchor down to be flush with the bone.A new small bone fastak¿ suture anchor with 2-0 fiberwire was used in an adjacent spot to complete the case.
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.This is a follow-up submission due to device evaluation.Complaint confirmed.The device met all material specifications as received.The evaluation revealed broken tip stress fracture on the returned driver.The most likely cause(s) of this type of event include over-insertion, not inserting the implant coaxial to the bone tunnel, or prying/leveraging the driver while the implant is still loaded.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.
Event or Problem Description
It was reported that during an atfl repair procedure, the driver shaft on the small bone fastak¿ suture anchor with 2-0 fiberwire broke as the anchor was being seated into the bone.All metal fragments were removed from the patient and the tip of the driver was removed from the anchor, however, the broken anchor had to be left in.The surgeon was able to trim the anchor down to be flush with the bone.A new small bone fastak¿ suture anchor with 2-0 fiberwire was used in an adjacent spot to complete the case.

• Brand Name: SUTURE ANCHOR, FASTAK, SMALL BONE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6411487
• Report Number: 1220246-2017-00075
• Device Sequence Number: 10947053
• Product Code: HWC
• UDI-Device Identifier: 10888867010137
• UDI-Public: 10888867010137
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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: 07/01/2021
• Device Catalogue Number: AR-1322-752SF
• Device Lot Number: 10058005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 04/20/2017
• 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