MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX PINPOINT ADAPTER; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72205038

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that during a case it was noticed that there was an issue with the acufex pinpoint adapter, it had the words ¿not for human use¿ printed on the inside of it.When the mishap was noticed it had already been sterilized and used during the case.The procedure was completed with the same device with no delay.There was no patient harm reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: 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.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A review of the handle drawing found that the only labeling on the device was to specify the logo, part number, batch number, ce mark, gridlines, and angle numerals.No official device labeling with the reported warning was found.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Internal complaint reference: case-(b)(4).

• Brand Name: ACUFEX PINPOINT ADAPTER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11356708
• MDR Text Key: 232794033
• Report Number: 1219602-2021-00364
• Device Sequence Number: 1
• Product Code: NBH
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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: 72205038
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/21/2021
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1