MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL 1.8MM W/3.5MM SHAFT FOR; ACCESSORIES,ARTHROSCOPIC

Model Number 7209506

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

It was reported that the surgeon connected the drill to the drill guide and it was inspected.It was found that when the rear end of the guide was aligned with the marking on the drill, the drill tip would come out 3 to 4 mm longer.No case involved all available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no other related failures.Factors that are known to contribute to the alleged fault/failure may be a component failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: DRILL 1.8MM W/3.5MM SHAFT FOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10423609
• MDR Text Key: 203475461
• Report Number: 1219602-2020-01271
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010474575
• UDI-Public: 03596010474575
• 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: 09/23/2020

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 Model Number: 7209506
• Device Catalogue Number: 7209506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1