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

Catalog Number	AR-1920S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
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 evaluation revealed frayed/cut suture ends on the returned device.Returned device sample is relatively small and has damaged ends, not able to perform stress test to confirm surgeon claim of being able to tear suture by hand.Suture anchor, eyelet, and driver were not returned for evaluation.At this time, the cause is undetermined.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 the suture anchor was implanted on the (b)(6) 2017 and removed on the (b)(6) 2017 because the suture was torn off.Follow-up on (b)(6) 2017: the incident caused no harm for the patient and no consequential damages appeared.They used another (b)(4) with a different lot number in the second surgery.The surgeon reported that he could tear the suture with his hands.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6630317
• Report Number: 1220246-2017-00205
• Device Sequence Number: 926403
• Product Code: HWC
• UDI-Device Identifier: 00888867022812
• UDI-Public: 00888867022812
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: 04/01/2018
• Device Catalogue Number: AR-1920S
• Device Lot Number: 759907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/09/2017
• 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