MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205345
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder cuff repair surgery, it was found that the planer head had debris falling off.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
One 4.5 incisor blade was returned for evaluation.Visual assessment of the device showed the blade is bent.Functional inspection was performed and the inner blade did not rotate freely within the outer blade, friction was felt in the unloaded condition.The inner blade showed abrasions at the distal tip and proximal end near the slough chamber.The outer blade showed corresponding abrasions on its edgeform teeth.The condition of the device indicates an excessive lateral load was placed on it during use.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BOXED INCISOR PLUS BL,(BX6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8881555
• Report Number: 1219602-2019-00943
• Device Sequence Number: 2048077
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 03596010251688
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 08/12/2023
• Device Catalogue Number: 7205345
• Device Lot Number: 50752620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/10/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 65