MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STONECUTTER ACR,EP-1,5.5 DSPL; SAW, POWERED, AND ACCESSORIES

Model Number	7205331
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the blade was shedding during the procedure.A backup device was available to complete the procedure without patient impact.
Additional Manufacturer Narrative
Three 5.5 ep-1 stonecutter burrs were returned for evaluation.Visual assessment of the burrs showed no evidence of debridement/shedding on the inner burr or outer sheath.Functional inspection was performed and the inner burrs rotated freely within the outer sheaths, no friction was felt in the unloaded condition.The reported shedding could not be confirmed.No root cause related to the manufacture of the device can be established.No further investigation is warranted at this time.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: STONECUTTER ACR,EP-1,5.5 DSPL
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7051511
• Report Number: 1219602-2017-01456
• Device Sequence Number: 2036721
• Product Code: HAB
• UDI-Device Identifier: 03596010251596
• UDI-Public: (01)03596010251596(17)220315(10)50652938
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: 7205331
• Device Catalogue Number: 7205331
• Device Lot Number: 50652938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1