MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS, 2.9, MAG-MINI, DISP. BLA; SAW, POWERED, AND ACCESSORIES

Model Number	72201509
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blade has left some metal flakes into the joint.The joint has been cleaned up.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.
Additional Manufacturer Narrative
One single 72201509 disposable 2.9mm full raduis mini magnetic abrader blade returned.These are sold as a box of six.This product is not intended to be or tested to be sold individually.The complaint stated: "it was reported that the blade has left some metal flakes into the joint.The joint has been cleaned up." the blade is in relatively good condition with exception of small dings on the blade bulb edges and skiving wear bands around the outer surface of the inner blade shaft.The degradation of the surface creates fine light metallic debris.This is a small scale device which is not intended to have excess pressure applied.No root cause related to the manufacture of the device was confirmed.Complaint history search revealed no other complaints for this production lot.

• Brand Name: FULL RADIUS, 2.9, MAG-MINI, DISP. BLA
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7646409
• Report Number: 1219602-2018-00840
• Device Sequence Number: 13498657
• Product Code: HAB
• UDI-Device Identifier: 03596010621665
• UDI-Public: (01)03596010621665(17)200515(10)50664372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/10/2018

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: 05/15/2020
• Device Model Number: 72201509
• Device Catalogue Number: 72201509
• Device Lot Number: 50664372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 10/09/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 60