MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8.5MM; BIT, SURGICAL

Catalog Number 72204043

Device Problem Break (1069)

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

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during an acl procedure, when removing the "8.5mm retrograde trunav drill" from the joint, the front part of the drill broke off.A wire was guided to the broken piece under x-ray control and pressed into the joint and recovered.A delay greater than 30 min took place, and it is unknown if a back-up device was available to complete the procedure.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 found contaminates, a mangled cutter that has been sheared off and missing actuator wire.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 review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip or an inadvertent impact event.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 8.5MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11506423
• MDR Text Key: 240394268
• Report Number: 1219602-2021-00543
• Device Sequence Number: 1
• Product Code: GFG
• 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: 09/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Catalogue Number: 72204043
• Device Lot Number: 4772485
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR