MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED DRILL PAC; ACCESSORIES,ARTHROSCOPIC

Model Number	71935069
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a meniscal root repair surgery, surgeon made four attempts to drill the tunnel using a cannulated drill pac and the acufex director mrr; however each time the dr missed the target spot by 5 mm.Surgery resumed after a delay greater than 30 minutes, by using a back-up cannulated drill which drilled exactly in the spot, however an additional bone hole was needed for these purpose, leaving a 2.8mm drill channels voids.Patient health status did not face any complication so far.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a meniscal root repair surgery, surgeon made four attempts to drill the tunnel using a cannulated drill pac and the acufex director mrr; however each time the dr missed the target spot by 5 mm.Surgery resumed after a delay greater than 30 minutes, by using a back-up cannulated drill, which drilled exactly in the spot, however an additional bone hole was needed for these purpose, leaving three 2.8mm drill channels voids.Patient health status did not face any complication so far.No further complications were reported.
Additional Manufacturer Narrative
B5.
Event or Problem Description
It was reported that, during a meniscal root repair surgery, surgeon made four attempts to drill the tunnel using a cannulated drill pac; however each time, the surgeon missed the target spot by 5 mm.Surgery resumed after a surgical delay greater than 30 minutes, by using a back-up cannulated drill which drilled exactly in the spot.No further complications were reported.
Additional Manufacturer Narrative
B5 was updated.H3, h6: the reported device was received for evaluation.A visual inspection revealed the cutting surfaces of the drill bit were chipped and worn.One of the cannulated sleeves was deformed at the proximal end and spiral wear marks were noted on the exterior surface.A functional evaluation found the drill bit fit in the returned cannula sleeves and there was no warping or off-axis rotation noted.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 evaluation was performed and found no further risk to the patient is anticipated as a result of the additional bone holes.No patient complications have been noted following the procedure.Since no further harm is anticipated no further clinical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include application of inappropriate lateral force and/or use of a faulty concomitant device.No containment or corrective actions are recommended at this time.

• Brand Name: CANNULATED DRILL PAC
• 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: 16513085
• Report Number: 1219602-2023-00341
• Device Sequence Number: 17702215
• Product Code: NBH
• UDI-Device Identifier: 00885556533284
• UDI-Public: 00885556533284
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2025
• Device Model Number: 71935069
• Device Catalogue Number: 71935069
• Device Lot Number: 20CCT0026E
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 05/26/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/20/2023; 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown