MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201108

Device Problem Break (1069)

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

Event Date 04/12/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that during an arthroscopy, when using 2.6mm drill bit spade for the 2.3mm bioraptor suture anchor to prepare hole for osteoraptor 2.3 anchor - drill had been used for hole preparation of 2 anchors in patient already.While drilling 3rd hole with use of drill guide, the blade of the drill snapped off and lodged in patient's cortical bone.The body of the drill was removed still attached to the jacobs chuck and handpiece.The blade/head of the drill lodged in the bone was removed with an alligator grasper.It was believed that the break was clean as no other parts of the drill could be seen.The procedure was completed with non-significant surgical delay using a back-up device.No further complications were reported.

• Brand Name: DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19214397
• MDR Text Key: 341429075
• Report Number: 1219602-2024-00904
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010595034
• UDI-Public: 03596010595034
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male