MAUDE Adverse Event Report: ARTHREX, INC. GRSPR,BLNT 2.75 MMSTR W/SR HNDL; ACCESSORIES,ARTHROSCOPIC

Catalog Number AR-11500SR

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/16/2015

Event Type  Injury  

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 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 using excessive force while manipulating tissue, or 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 the event happened during surgery.A piece from the jaw broke into patient's body.There was an attempt to remove the broken fragment, but it was not possible to find the broken piece.After two hours the surgery was aborted due to the risk that the patient will loose too much blood.At the moment the patient has got metal in his joint.Follow-up investigation: no follow-up surgery was scheduled.The patient has no problems and isn't injured.The x-rays show the fragment, but has caused no problems.

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.Complaint confirmed.The break is at the back pocket near the center of the jaw.The device met all material specifications as received.Complainant's event typically caused by using excessive force while manipulating tissue, or 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 the event happened during surgery.A piece from the jaw broke into patient's body.There was an attempt to remove the broken fragment, but it was not possible to find the broken piece.After two hours the surgery was aborted due to the risk that the patient will loose too much blood.At the moment the patient has got metal in his joint.Follow-up investigation: no follow-up surgery was scheduled.The patient has no problems and isn't injured.The x-rays show the fragment, but has caused no problems.

• Brand Name: GRSPR,BLNT 2.75 MMSTR W/SR HNDL
• 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: 5535255
• MDR Text Key: 41474079
• Report Number: 1220246-2016-00139
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-11500SR
• Device Lot Number: 1221539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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