MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE CANNULATED 8.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number 7209737

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event 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.

Manufacturer Narrative

Internal complaint reference: (b)(4).H3, h6: 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 8.5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12071626
• MDR Text Key: 258719229
• Report Number: 1219602-2021-01423
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010541987
• UDI-Public: 03596010541987
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 7209737
• Device Catalogue Number: 72203164
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 07/23/2021
• Supplement Dates FDA Received: 06/25/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1