MAUDE Adverse Event Report: ARTHREX INC. SUTURE ANCHOR, MICRO CORKSCREW FT; SCREW, FIXATION, BONE

Catalog Number	AR-1318FT-40
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
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.Device history record review revealed nothing relevant to this event.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.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was originally reported that the suture anchor driver broke off and/or bent, impacting on the suture and causing it to fray.Two of the anchors could not be retrieved and were left in the patient.Two different lots were used successfully.Patient: (b)(6) male; (b)(6).Case: distal radius.Follow-up investigation: three units of the same lot did not work as intended.None of the anchors themselves broke.Two of the anchors had the driver break-off in the anchor and one of the drivers crimped shut, causing the suture to fray.One anchor was successfully retrieved.Two (2) anchors were left in bone, sitting flush with a piece of the driver inside the anchor.All suture was retrieved.The three drivers in question are being returned for evaluation.To complete the procedure two anchors/drivers from a different lot were used without issue.
Event or Problem Description
It was originally reported that the suture anchor driver broke off and/or bent, impacting on the suture and causing it to fray.Two of the anchors could not be retrieved and were left in the patient.Two different lots were used successfully.Patient: (b)(6) male; (b)(6).Case: distal radius.Follow-up investigation: three units of the same lot did not work as intended.None of the anchors themselves broke.Two of the anchors had the driver break-off in the anchor and one of the drivers crimped shut, causing the suture to fray.One anchor was successfully retrieved.2 anchors were left in bone, sitting flush with a piece of the driver inside the anchor.All suture was retrieved.The three drivers in question are being returned for evaluation.To complete the procedure two anchors/drivers from a different lot were used without issue.
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.Device history record review revealed nothing relevant to this event.The evaluation revealed that the driver"s distal square drive tip was broken-off.Additionally, the driver's distal square driver tip was bent and damaged (pinched between the walls).The driver met all material specifications as received.Complainant's event is typically caused by 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 causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7185387
• Report Number: 1220246-2017-00517
• Device Sequence Number: 1355329
• Product Code: HWC
• UDI-Device Identifier: 00888867008526
• UDI-Public: 00888867008526
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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 Expiration Date: 01/01/2022
• Device Catalogue Number: AR-1318FT-40
• Device Lot Number: 10111921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/22/2018
• 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
• Patient Age: 46 YR