MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLUTED DRILL BIT W/ STOP 2.9MM ANCH; ACCESSORIES,ARTHROSCOPIC

Model Number	72202404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the drill bit broke on the fish lip during the dislocation of shoulder joint procedure, some pieces remain in the bone, and finally pieces were removed.The procedure was completed with a smith and nephew backup device.There was a delay greater than 30 min.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images show a damaged drill bit.A visual inspection found that the device was received in original packaging.Remnants of biological debris along the shaft.The drill bit was broken medially and the distal portion of the drill bit was not received.There is evidence of denting and dimpling along the remainder of the drill bit indicating use.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 concluded this was an isolated issue.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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: FLUTED DRILL BIT W/ STOP 2.9MM ANCH
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11963348
• Report Number: 1219602-2021-01316
• Device Sequence Number: 16891597
• Product Code: NBH
• UDI-Device Identifier: 03596010652409
• UDI-Public: 03596010652409
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 72202404
• Device Catalogue Number: 72202404
• Device Lot Number: 50732555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention