MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72203450

Device Problem Illegible Information (4050)

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

Event Date 04/21/2020

Event Type  Injury  

Event Description

It was reported that during acl repair when using the acufex pinpoint bullet to make the tibia tunnel, it was found that the numbers could not be seen, they are blurred.No significant delay and the procedure was finished with the same device.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

One 72203450 acufex pinpoint bullet 4 pt 6.5mm reported on as used for treatment but was not returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.Due to product unavailability, evaluation was limited.If further information becomes available the complaint may be revisited.It was noted that a marking visibility issue was found outside the patient.A customer photo sent showed two bullet items.Both had broken distal tips.It could not be confirmed whether these are smith + nephew items.S+n bullet calls for a steel head.The bullets in the photo appears to be an alternate metal or appears different due to anodization.The second photo is of the surgi tray they were linked to, was identified as an acufex item.Per instructions for use: these instruments are designed for repeated use with proper care and handling.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Complaint history review for three years prior indicated no similar allegations for the product reported.Batch review was unattainable without a valid lot number reported.No further action warranted at this time.

Event Description

It was reported that during acl repair when using the instrument to make the tibia tunnel, it was found that the numbers could not be seen, they are blurred.No significant delay and the procedure was finished with the same device.No other complication were reported.Results of investigation showed that both pin point bullets had broken distal tips.This means that the event may necessitate medical or surgical intervention, such as retrieval of device fragments from the operative field which makes it a reportable event.

• Brand Name: ACUFEX PINPOINT BULLET 4 POINT - 6.5
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10068405
• MDR Text Key: 191378354
• Report Number: 1219602-2020-00795
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554026917
• UDI-Public: 885554026917
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1