MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 9MM; BIT, SURGICAL

Model Number	72204044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the surgery the retrograde drill could not be opened in the joint and the wire was broken.All the broken pieces were removed from the patient.No significant delay or other complications were reported.The surgery was completed using a smith and nephew back-up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned without any of the complementary components.The internal wire appeared to be connected to the rotating cutter.There was significant debris within the cutter and on the shaft.A functional evaluation concluded that the device cutter is unable to rotate out of the shaft fully.It seemed to be connected to the grey slider still and moves slightly, but was not able to fulfill its intended purpose.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.The cannulated power drill must always be set to forward when drilling tunnels and retrograde-drilling sockets.Prior to deploying the cutting blade, ensure that the guide wire is retracted within the groove approximately 1.5 inches (38 mm) within the retrograde drill shaft and is not in the drill head window.The groove in the guide wire provides tactile feedback that it is retracted to the proper position.This will prevent possible device failure.The device is intended to drill in a retrograde motion only when cutting blade is deployed.Antegrade drilling while the cutting blade is deployed may result in device failure.Use only the smith & nephew devices provided in the retrograde drill kit.As with any surgical instrument, careful attention must be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.The complaint was confirmed.Factors that could have contributed to the reported event include failure to retract guide wire, excessive force during use, use of the reverse function when drilling, or improper drilling direction when the cutting blade is deployed.

• Brand Name: RETROGRADE DRL 9MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11221252
• Report Number: 1219602-2021-00186
• Device Sequence Number: 3786108
• Product Code: GFG
• UDI-Device Identifier: 00885554037739
• UDI-Public: 00885554037739
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 07/09/2024
• Device Model Number: 72204044
• Device Catalogue Number: 72204044
• Device Lot Number: 4906206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/24/2021
• Supplement Report FDA Received Date: 03/01/2021
• 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