MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE CANNULATED 9.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203165
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during an acl procedure, the sizing etchings on the clancy flexible reamer warn off- it was not able see the depth measurement under scope.Procedure was successfully completed with the same device.No significant delay and no patient injuries were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: DRILL FLEXIBLE CANNULATED 9.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12071694
• Report Number: 1219602-2021-01425
• Device Sequence Number: 4899262
• Product Code: NBH
• UDI-Device Identifier: 03596010654588
• UDI-Public: 3596010654588
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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 Catalogue Number: 72203165
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1