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

Catalog Number 72204044

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).The sample is under evaluation by the manufacturing site.

Event Description

It was reported that, during an unspecified surgery, the end of 9.0 mm acufex trunav retrograde drill could not be deployed: it flipped over on itself.It is unknown how the procedure was finished and if it was delayed.The patient was not harmed.Preliminary results of investigation have concluded that the orange depth tube had been chewed up at the distal tip, which means that plastic debris may have been released into the patient and this is a reportable event.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 during treatment, was retuned for evaluation.Evaluation of the drill did not confirm the issue.The actuator engaged and interacted with the cutter blade.It was able to articulate.Photos revealed that the attached orange depth tube had been chewed up at the distal tip.The estimated bone tunnel length may have been shallow.Debris may not have been adequately cleared from the window to allow proper articulation of the blade.Per instructions for use: read these instructions completely prior to use.Warning: if resistance is felt when deploying the cutting blade, confirm that the black laser line on the drill head is visible out of the tunnel, guide wire is pulled back within the groove and no longer in the drill head window, and bone debris is cleared from drill head window.Take caution if bone debris removal is necessary to prevent any damage to the wire attached to the cutting blade.Note: to ensure that the cutting blade opens in the visual field, slowly rotate the retrograde drill until the ¿+¿ on the distal drill head or on the external orange cylinder is completely visible.Complaint history review for three years prior indicated no similar allegations for the product code reported.Batch review was unattainable without a valid lot number provided.Further investigation is not warranted at this time.

• Brand Name: RETROGRADE DRL 9MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9975211
• MDR Text Key: 188404246
• Report Number: 1219602-2020-00663
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72204044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other