MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AMR TIP ARM DRCTR ACL GDE; ACCESSORIES,ARTHROSCOPIC

Model Number 7205519

Device Problem Failure to Align (2522)

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

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zipcode (b)(6).

Event Description

It was reported that during an acl surgery, the acufex drill guide was not lined up.There was not a back-up available and it is unknown how the procedure was completed.There was no delay and no patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.H3, h6: the reported director drill guide aimer, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the aimer did not align properly.An exact root cause cannot be determined with confidence without the return of the device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMR TIP ARM DRCTR ACL GDE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9565610
• MDR Text Key: 174324005
• Report Number: 1219602-2020-00051
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010373281
• UDI-Public: 03596010373281
• 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: 02/19/2020

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 Model Number: 7205519
• Device Catalogue Number: 7205519
• Device Lot Number: 50676399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1