MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.5MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	AR-8550BC
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2016
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.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 user mechanical damage to device such as hitting the device with another device or excessive bending forces being applied during use.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 the shaver caused metal debris.This was also visible under post-surgical mri.Shavings remained in the patient.Surgery performed was a sub-acrmoalia decompression.Surgery was successfully finished,using another identical shaver.
Additional Manufacturer Narrative
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.Complaint confirmed.The evaluation revealed metal gouging on the id of outer tube and od of inner tube by distal end.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device or excessive bending forces being applied during use.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 the shaver caused metal debris.This was also visible under post-surgical mri.Shavings remained in the patient.Surgery performed was a subacromial decompression.Surgery was successfully finished,using another identical shaver.

• Brand Name: BONE CUTTER,5.5MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5856341
• Report Number: 1220246-2016-00333
• Device Sequence Number: 16247417
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2016

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: 05/01/2021
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 10044211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 08/25/2016
• 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