MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,SLAP,4.5MM DSPL,DYO PWR /6; SAW, POWERED, AND ACCESSORIES

Catalog Number	7209335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a portion of metal tip of burr broke off into patient shoulder.All pieces retrieved.No apparent harm to the patient.
Additional Manufacturer Narrative
Additional information visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Event description correction.Not a health professional leave it without any value company representative and no health professional usage of device, initial use.
Event or Problem Description
It was reported that during a shoulder arthroscopy, a portion of metal tip of burr broke off into patient shoulder.All pieces retrieved.No apparent harm to the patient.It is unknown if there was back-up device available and if there was a delay in the case.Attempts were made to retrieve further information but no response was received from the complainant.
Additional Manufacturer Narrative
One 4.5mm slap burr was returned for evaluation.Visual assessment of the device confirmed the hooded portion of the outer sheath has broken off at the weldment and was not returned.Functional inspection was performed and the inner burr did not rotate freely within the outer blade, friction was felt in the unloaded condition.The condition of the device indicates it was subjected to excessive side loading during use.Per the devices instructions for use ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.
Event or Problem Description
It was reported that during a shoulder arthroscopy, a portion of metal tip of burr broke off into patient shoulder.All pieces retrieved.No apparent harm to the patient.It is unknown if there was back-up device available and if there was a delay in the case.Attempts were made to retrieve further information but no response was received from the complainant.

• Brand Name: BURR,SLAP,4.5MM DSPL,DYO PWR /6
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8207487
• Report Number: 1219602-2019-00001
• Device Sequence Number: 19253134
• Product Code: HAB
• UDI-Device Identifier: 03596010463418
• UDI-Public: 03596010463418
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2019

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: 03/01/2021
• Device Catalogue Number: 7209335
• Device Lot Number: 50970672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/28/2019; 06/03/2019
• Initial Report FDA Received Date: 01/01/2019
• Supplement Report FDA Received Date: 01/29/2019; 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1