MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 12MM; BIT, SURGICAL

Model Number 72204050

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 07/31/2020

Event Type  Injury  

Event Description

It was reported that during arthroscopy procedure, the product broke inside the patient.No delay and a back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during lca+lcp arthroscopy procedure, the product broke inside the patient and the pieces were successfully removed.No delay and a back up was available to complete the procedure.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

H10, h2: additional information on a3 and b5.

Manufacturer Narrative

One 72204050 retrograde 12.0mm drill used in treatment, was not returned for evaluation.Evaluation was limited.Instructions for use (ifu) should be read in full prior to use.Per ifu ¿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.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.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 failure that supported the allegation.Ifu and insert card contain recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the device show cause that the material was related to the reported failure.There was no evidence to suggest that product from this family did not pass requirements upon release for use.No additional actions required at this time.

Manufacturer Narrative

The reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection found the actuator wire and cutter are detached from the device.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed, and the root cause was associated with unintended use of the device factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 12MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10439296
• MDR Text Key: 203999036
• Report Number: 1219602-2020-01292
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037791
• UDI-Public: 00885554037791
• 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,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204050
• Device Catalogue Number: 72204050
• Device Lot Number: 4888951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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 Outcome(s): Required Intervention; Other
• Patient Sex: Male