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

Catalog Number AR-13975SR

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2017

Event Type  Injury  

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 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.

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 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
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6511012
• MDR Text Key: 73363419
• Report Number: 1220246-2017-00137
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867015838
• UDI-Public: 00888867015838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR