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

Catalog Number	72201108
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem 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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4) h10 h3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The drilling head fractured just below the proximal end of the cutting surfaces.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that a procedural variance could not be ruled out as a likely contributory factor.The ifu does warn, ¿excessive force applied to the instrument can result in the instrument¿s failure." the root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device, off-axis insertion, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC
• Common Device Name: 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
• Report Number: 1219602-2024-00904
• Device Sequence Number: 15179363
• Product Code: NBH
• UDI-Device Identifier: 03596010595034
• UDI-Public: 03596010595034
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72201108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male