MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRAIGHT CUT RASP; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71935043
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the instrument was used in a arthroscopic latarjet surgery case and that small metal pieces were falling off the rasp into the joint.The surgeon tried to get rid of as many as possible but there was still some left.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned straight cut rasp indicated no obvious signs of damage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Magnified photos found no metal flaking with no damage to the teeth.A functional simulation could not replicate that stated complaint.A review of complaint history on the listed part revealed no additional complaints for the listed part.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: STRAIGHT CUT RASP
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7436649
• Report Number: 1020279-2018-00766
• Device Sequence Number: 16191923
• Product Code: MDM
• UDI-Device Identifier: 00885556645949
• UDI-Public: 00885556645949
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71935043
• Device Lot Number: 17ATD0005
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other