MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8MM; BIT, SURGICAL

Catalog Number 72204042

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during an arthroscopy, the 8mm acufex trunav retrograde drill has broken down.The procedure was successfully completed without delay using a back-up device.No patient injuries or 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

H10 h3, h6: one retrograde 8.0mm drill used for treatment, was not returned for evaluation.Evaluation was limited.Instructions for use and insert card contain recommendations and precautionary statements for proper use of product.A customer photo was sent to assist with evaluation.The distal slide actuator, plunger and proximal shaft area was separated from the rest of the device.The complaint was revisited, which pointed to the inadequate clearing of debris within the blade cavity area as a factor compromising the product performance and integrity.The condition encourages the user to apply incompatible excess force with attempted use.Instructions for use along with insert card technique steps are specific and should be read in full prior to use.Per instructions for use ¿use only the smith and nephew devices provided in the retrograde drill kit.The cannulated power drill must always be set to forward when drilling tunnels and retrograde-drilling sockets.The device may fail if the cutting blade is not at full rotational speed prior to contacting bone and throughout retrograde drilling.Excessive force can result in instrument failure.The device is only intended to drill in a retrograde motion when cutting blade is deployed.Antegrade drilling while cutting blade is deployed may result in device failure.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.There was no evidence to suggest that product from this family did not pass requirements upon release for use.

• Brand Name: RETROGRADE DRL 8MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9975269
• MDR Text Key: 192139622
• Report Number: 1219602-2020-00664
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204042
• Device Lot Number: 4899140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female