MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8MM; BIT, SURGICAL

Model Number 72204042

Device Problem Crack (1135)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during an arthroscopic procedure, when the "8.0mm acufex trunav retrograde drill" was activated to open the blade, it was found that the material was already broken and the cutter blade could not be opened.There was no break inside the patient.The procedure was successfully completed without delay using a back-up device.No further complications were reported.

Manufacturer Narrative

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 review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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: RETROGRADE DRL 8MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12026302
• MDR Text Key: 257514944
• Report Number: 1219602-2021-01385
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037715
• UDI-Public: 00885554037715
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204042
• Device Catalogue Number: 72204042
• Device Lot Number: 4937153
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1