MAUDE Adverse Event Report: ARTHREX INC. BIO-CORKSCREW SUTURE ANCHOR 5MM W/2 #2 FW; SCREW, FIXATION, BONE

Catalog Number	AR-1920BF
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/05/2017
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.At this time, it cannot be determined how the device may have caused or contributed to the incident.An evaluation of the device cannot be performed as the device was discarded by the facility.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.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 originally reported via medwatch report (b)(4) that a biocomposite anchor, ar-1920bf, broke at the run out of insertion.Medwatch report stated that the device was accurately used by surgeon.Per medwatch report the device is not available for evaluation.Follow-up investigation: it was reported that the procedure was a kidner gastroc recession with evans osteotomy.The anchor broke in the middle of the procedure and a portion of the anchor remains in the patient.The head of the anchor stayed in the bone, but the suture broke away so the tissue was unable to be tied down.The case was completed using another anchor to tie the tissue down.The surgeon's technique did not change due to the suture breaking away from the anchor.

• Brand Name: BIO-CORKSCREW SUTURE ANCHOR 5MM W/2 #2 FW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6739477
• Report Number: 1220246-2017-00287
• Device Sequence Number: 1236557
• Product Code: HWC
• UDI-Device Identifier: 00888867022706
• UDI-Public: 00888867022706
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 07/25/2017

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: 05/01/2018
• Device Catalogue Number: AR-1920BF
• Device Lot Number: D5159
• 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: 07/14/2017
• Initial Report FDA Received Date: 07/25/2017
• 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