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

Model Number 72204044

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case: (b)(4).

Event Description

It was reported that during an arthroscopy, there was no laser mark engraved on the dedicated guide wire of the retrograde, the device could not be measured depth and used properly.The procedure was completed with a s+n back-up device.No significant delay was reported, and no patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the drill tip guidewire laser markings found laser markings are required and are specified.A visual inspection found scratches on the blade, proximal end and on the laser mark.The laser mark was present.A review of the customer provided image shows a blurry image of a device without a laser mark.There is no product identification information shown on the device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.The returned device contained the appropriate laser markings and the provided images could not confirm the product identification information, 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.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the pictured device and the reported incident.A review of a process summary from the supplier found laser marking is performed and visual verification occurs during operation.A review of the drill tip guidewire laser markings found laser markings are required and the location is specified.A visual inspection found scratches on the blade, proximal end, and on the laser mark.The laser mark was present.A review of the customer provided image shows two devices; one with a laser mark and one without a laser mark.There is no product identification information shown on the device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was confirmed, but the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the investigation findings include the return of an incorrect device, or the comparison of two different part numbers.No containment or corrective actions are recommended 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
• 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: 11917398
• MDR Text Key: 253761858
• Report Number: 1219602-2021-01274
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00885554037739
• UDI-Public: 00885554037739
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204044
• Device Catalogue Number: 72204044
• Device Lot Number: 4906206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• 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