MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 5.5MM; BIT, SURGICAL

Model Number	72204037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy procedure, the blade of the retrograde drl 5.5mm could not be deployed and the wire broke after inserting the drill into the joint.All broken pieces were removed from the patient.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).H3, h6: part of the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as pre-cautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A visual inspection of the returned device found that it was returned outside of its original packaging.The drill tip guidewire was not in the returned package.The drill bit and suture passer tube with the monofilament still inside were returned.The blade has not been deployed, and there is debris in the bit and in the joints of the blade.The actuator wire is still attached to the blade.The suture passer has a slight curve in the shaft and the monofilament is intact.A functional evaluation of the device found that the blade did not deploy as-is when returned.When the debris was removed from the joints, the blade rotated freely by hand, but did not deploy on its own.Per case details, all the broken pieces were removed from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint of non-deployment and mechanical jam was confirmed.Factors that could have contributed to the reported event include failure to remove debris from the drill head window, failure to retract the guidewire far enough back before attempting to deploy the blade, and attempting to deploy the blade while still inside the bone tunnel.The complaint for broken guide wire was not confirmed and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.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.

• Brand Name: RETROGRADE DRL 5.5MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12362840
• Report Number: 1219602-2021-01778
• Device Sequence Number: 3821609
• Product Code: GFG
• UDI-Device Identifier: 00885554037661
• UDI-Public: 00885554037661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2024
• Device Model Number: 72204037
• Device Catalogue Number: 72204037
• Device Lot Number: 4937096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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; Required Intervention