MAUDE Adverse Event Report: ARTHREX, INC. FIBERWIRE GRAPSER W/ SR HANDLE; ACCESSORIES, ARTHROSCOPIC

Catalog Number	AR-13975SR
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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.Complainant's event typically caused by applying excessive force while grasping and manipulating tissue, or when applying excessive leveraging forces.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.Device requested but not yet received.
Event or Problem Description
It was reported that during a rotator cuff repair procedure, the surgeon was using the fiberwire grasper with sr handle to grasp the biceps tendon.The upper jaw of the grasper broke-off into the patient's joint.The surgeon attempted to locate the jaw fragment with the scope however, could not locate it.The surgeon then had an x-ray brought in and was able to confirm the location of the jaw fragment but was unable to retrieve it.A second surgery is undetermined at the moment and the surgeon will watch for any symptoms being caused by the device fragment.
Additional Manufacturer Narrative
Patient demographics (date of birth, 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 has a broken jaw.The device met all material specification as received.Broken jaw piece and hand instrument were not returned.Complainant's event typically caused by applying excessive force while grasping and manipulating tissue, or when applying excessive leveraging forces.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 a rotator cuff repair procedure, the surgeon was using the fiberwire grasper with sr handle to grasp the biceps tendon.The upper jaw of the grasper broke-off into the patient's joint.The surgeon attempted to locate the jaw fragment with the scope however, could not locate it.The surgeon then had an x-ray brought in and was able to confirm the location of the jaw fragment but was unable to retrieve it.A second surgery is undetermined at the moment and the surgeon will watch for any symptoms being caused by the device fragment.

• Brand Name: FIBERWIRE GRAPSER W/ SR HANDLE
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6511012
• Report Number: 1220246-2017-00137
• Device Sequence Number: 16330402
• Product Code: NBH
• UDI-Device Identifier: 00888867015838
• UDI-Public: 00888867015838
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Catalogue Number: AR-13975SR
• Device Lot Number: 48628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2017
• Supplement 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
• Patient Age: 68 YR