MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RASP 5MM HALF ROUND; ACCESSORIES,ARTHROSCOPIC

Model Number 72201733

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 08/10/2020

Event Type  Injury  

Event Description

It was reported that during an acl when using the rasp the tip broke off while raping the acl tibial tunnel, the broken end was easily removed.The procedure was completed with a backup device and no significant delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of the customer-supplied photographs was performed and observed the tip is separated from the instrument.The complaint was confirmed.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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference: (b)(4).H6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A visual inspection revealed the distal tip of the device was received taped to the device as it was broken from the instrument.A review of the customer-supplied photographs was performed and observed the tip is separated from the instrument.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: RASP 5MM HALF ROUND
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10879071
• MDR Text Key: 217659990
• Report Number: 1219602-2020-01901
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010608246
• UDI-Public: 03596010608246
• 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,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201733
• Device Catalogue Number: 72201733
• Device Lot Number: 50558097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 04/09/2021; 07/01/2021
• Supplement Dates FDA Received: 04/12/2021; 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention