MAUDE Adverse Event Report: ARTHREX INC. FIBERLOOP, #2, BLUE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-7234
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
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.This is one of two submissions from the same event.The other is (b)(4).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 typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue or hitting bone with the needle.There is a label on the device warning the user against re-sterilizing, reusing, hitting bone or use of excessive force as these may result in needle breakage or patient injury.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff repair the tip of the ar-13991n needle broke off.They were unaware that the tip was still in the patient until it showed up on x-ray.It was not retrieved.During the same procedure the fiberloop #2 suture, ar-7234, broke off.It is still in the patient.There is a revision surgery scheduled on (b)(6) 2017 to remove the fiberloop and possibly the needle tip.Follow-up investigation: during the (b)(6) 2017 procedure the tip of the surefire scorpion needle, ar-13991n, lot 10113253 ((b)(4)) broke off and remained in the patient.Also, the needle tip and some suture broke off and remained in the patient from the ar-7234, fiberloop, #2 blue, lot 10026082 ((b)(4)).The revision surgery took place on (b)(6) 2017, at a different facility then the original surgery and was performed by a different surgeon than the original procedure surgeon.During the revision the surgeon was able to remove the (b)(6) 2017 unretrieved suture and unretrieved needle tip from the ar-7234 from the patient.The (b)(6) 2017 unretrieved needle tip from the ar-13991n surefire scorpion needle was not found and remains unretrieved.Patient was a male, (b)(6).Devices and any retrieved pieces are being kept by the facility and are not being returned for evaluation.

• Brand Name: FIBERLOOP, #2, BLUE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7178426
• Report Number: 1220246-2017-00512
• Device Sequence Number: 16367338
• Product Code: GAT
• UDI-Device Identifier: 00888867041677
• UDI-Public: 00888867041677
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K041553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 02/01/2022
• Device Catalogue Number: AR-7234
• Device Lot Number: 1002608202012021
• 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: 12/20/2017
• Initial Report FDA Received Date: 01/10/2018
• 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: 22 YR