MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCPC CANN 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72202971
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of flexible reamer broke off during acl procedure, the reaming had already been completed both the shaft and the tip of the flexible reamer were recovered with grasper.There was no delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A 72202971 4.5mm flexible endoscopic cannulated drill used in treatment, was returned for evaluation.The instrument is bent.The drill has been stressed at the tip/spiral transition.The drill tip has been broken off the coiled section.The coils have been damaged, they are bowed, permanently sprung and are no longer concentric from torque force.The broken tip has visible damage.Cutting edges have considerable wear and are rolled over.Per complaint details, currently we are unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided after the reaming was complete both the shaft and the tip of the flexible reamer were recovered with a grasper.Since there was no delay or further complications reported; no further clinical/medical assessment is warranted at this time.Should additional medical information be provided, this complaint will be re-assessed.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.

• Brand Name: DRILL FLEXIBLE ENDOSCPC CANN 4.5MM
• 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: 10440115
• Report Number: 1219602-2020-01295
• Device Sequence Number: 11375763
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: 03596010654526
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50362399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male