MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCPC CANN.DRL.BIT 4.5 STRL; BIT, DRILL

Model Number	7207315
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, the cannulated drill bit snapped in the femoral tunnel opening.The issue arose when the guide wire and the reported device bent whilst drilling.All the pieces were removed and the tunnel was re-drilled.Surgery was resumed, after a non-significant delay, with the same device.No further complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿b5¿.
Event or Problem Description
It was reported that, during an anterior cruciate ligament reconstruction, the cannulated drill bit snapped in the femoral tunnel opening.The issue arose when the guide wire and the reported device bent whilst drilling.All the pieces were removed, using a tapered awl and a gillies forceps.The original bone hole was used, no additional hole was required; therefore, no void was left in the patient.Surgery was resumed, after a non-significant delay, with the same device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided images finds the complaint device, along with a similar device.The complaint device has the distal end fractured away from the shaft.No relevant clinical information has been provided.Therefore, a thorough medical investigation cannot be rendered, nor could the clinical root cause of the reported failure be determined.Per the information provided by the sales rep.All the pieces were retrieved using a tapered awl and a gillies forceps using the same drill hole no additional hole was required.Based on the information provided, the surgeon was resumed the surgery after a non-significant delay, with the same device with no other complications.According to the report, the patient is progressing as usual in rehab.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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H6: health effect - clinical code.

• Brand Name: ENDOSCPC CANN.DRL.BIT 4.5 STRL
• Common Device Name: BIT, DRILL
• 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: 15104129
• Report Number: 1219602-2022-01049
• Device Sequence Number: 5187732
• Product Code: HTW
• UDI-Device Identifier: 03596010425409
• UDI-Public: 03596010425409
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2022

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 Model Number: 7207315
• Device Catalogue Number: 7207315
• Device Lot Number: 2089120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 09/01/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/01/2022; 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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