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

Model Number	72202971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the drill flexible endoscopy was broke.Incident occurred while setting-up to the procedure.A back-up device was available and no delays occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, 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 subject device and the reported incident.A complaint history review concluded this was a repeat issue.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 review of the customer provided image found the shaft was broken between the 60 and 70 marking on the shaft.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that the drill flexible endoscopy was broken.Incident occurred while setting-up to a knee acl.A back-up device was available and no delays occurred.No further complications reported.

• 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
• MDR Report Key: 11781549
• Report Number: 1219602-2021-01034
• Device Sequence Number: 17058713
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: 03596010654526
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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 Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50757804
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/06/2021; 10/19/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/10/2021; 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1