MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,5.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Model Number 7205307

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

During a synovectomy utilizing a full radius blade, it was reported that the blade began shedding just after starting to use.The procedure was completed with a back-up device.It was reported that there were no anatomy or procedure exceptions.No tissue was resected.The surgeon said all visible pieces were removed, however there was possibility that some small pieces remained.The surgeon felt seizing right from the beginning.There was a 15 minute delay in the procedure.There were no reports of patient¿s injuries or complications.

Manufacturer Narrative

Device evaluation: one device was returned for evaluation.The device was dimensionally evaluated for total indicator runout and confirmed to meet specification.The inner shaft overall length was measured to be 6.222 (6.220 +/-.010), and the outer shaft overall length was a measured to be 5.224 (5.226 +/-.010).The device was visually evaluated and scoring was identified along the shaft of the device.Damage of the inner edgeform was observed.Also metallic fragments consistent with metal debris shed from the device are lodged in the interior of the shaft.The failure mode is confirmed; however the root cause is attributed to excess force placed on the device during use.The excess force cause the inner blade to come in contact with the outer blade causing metal debris to be removed from the inner and outer blades at the point of contact.(b)(4).

• Brand Name: FULL RADIUS BLADE,5.5MM DSPL. EP-1
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4536014
• MDR Text Key: 16187747
• Report Number: 1219602-2015-00027
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205307
• Device Catalogue Number: 7205307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1