MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL,CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES

Model Number	7205335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blade was not cutting tissue, it was removed from the patient to check what happens, and then, it was observed that internal part of the blade was broken.The blade broke inside the patient, all pieces were removed.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.There is insufficient information to determine the root cause.
Additional Manufacturer Narrative
This product is sold as a box of three devices.They are not intended to be sold individually.The device is used.It has attained obvious damages.The shaft is visibly scratched, bowed and bent.This product is intended to only have one curve which angles the distal tip at a 12.5 to 14.5 degree angle.There should be no other curve/bend of the shaft.The device can no longer be tested due to the condition.Excess force has been applied to the product.No root cause related to the manufacture of this device was determined.

• Brand Name: FULL RADIUS BL,CONCAVE EP-1 (BX 3)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7516671
• Report Number: 1219602-2018-00593
• Device Sequence Number: 1385853
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: (01)03596010251626(17)200329(10)50688420
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2018

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: 03/29/2020
• Device Model Number: 7205335
• Device Catalogue Number: 7205335
• Device Lot Number: 50688420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 06/14/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 05/31/2018; 06/15/2018
• Patient Sequence Number: 1