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

Model Number 72204044

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/16/2020

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction, when using the trunav retrograde drill 9mm in the femoral cortex, it was found that the tip was detached.The tip of the device was removed from the patient.The procedure was completed without delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72204044 retrograde drill used in treatment, has not retuned for evaluation.Without the reported product, a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.However the customer has provided an image.The information provided states: ¿during acl reconstruction, when using the trunav retrograde drill 9mm in the femoral cortex, it was found that the tip was detached¿.Visual assessment of image confirms breakage.An exact root cause cannot be determined with confidence.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Complaint history review indicated a similar allegation for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.Occurrence rate of allegations are monitored via surveillance.No further investigation is warranted at this time.

• Brand Name: RETROGRADE DRL 9MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10383249
• MDR Text Key: 202162241
• Report Number: 1219602-2020-01212
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037739
• UDI-Public: 00885554037739
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204044
• Device Catalogue Number: 72204044
• Device Lot Number: 4899147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention