MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO ARTHRO-PIERCE INSTR 45 L; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7210226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an unspecified arthroscopic procedure, while stitching the articular lip of the shoulder joint, the arthro-pierce instrument broke.The doctor removed all the fragments of the broken arthro-pierce instrument.The procedure was successfully completed with non-significant surgical delay using a s+n back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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.An analysis of the customer provided image found that the jaw of the arthro-pierce instrument was broken.The root cause of the reported event could not be determined.Factors that could have contributed to the failure include excessive force on the device or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.Internal complaint reference: (b)(4).H8: updated to unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).B5: event description updated.
Event or Problem Description
It was reported that during an unspecified arthroscopic procedure, while stitching the articular lip of the shoulder joint, the arthro-pierce instrument broke.The doctor removed all the fragments of the broken arthro-pierce instrument with arthroscopic forceps.The procedure was successfully completed with non-significant surgical delay using a s+n back-up device.No further complications were reported.

• Brand Name: MTO ARTHRO-PIERCE INSTR 45 L
• 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: 15545412
• Report Number: 1219602-2022-01483
• Device Sequence Number: 14851268
• Product Code: NBH
• UDI-Device Identifier: 03596010601377
• UDI-Public: 3596010601377
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2023

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 Catalogue Number: 7210226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 10/25/2023; 10/25/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/29/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown