MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RASP, 5MM HALF ROUND; ACCESSORIES,ARTHROSCOPIC

Model Number	72201733
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the shaft of rasp broke, all pieces were removed from the patient's anatomy.No patient injury was reported.
Additional Manufacturer Narrative
One 5mm half round rasp was returned for evaluation.Visual assessment confirmed the reported complaint of breakage.The distal tip has broken off.The shaft is bent.Dimensional assessment of the device confirmed it meets print specification.The condition of the device indicates it was subjected to excessive force during use.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Further investigation is not required at this time.

• Brand Name: RASP, 5MM HALF ROUND
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7589811
• Report Number: 1219602-2018-00721
• Device Sequence Number: 11059633
• Product Code: NBH
• UDI-Device Identifier: 03596010608246
• UDI-Public: (01)03596010608246(10)50520922
• Combination Product (Y/N): N
• PMA/510(K) Number: D164484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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 Model Number: 72201733
• Device Catalogue Number: ED72201733
• Device Lot Number: 50520922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR