MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 35 DEGREE UP; ACCESSORIES,ARTHROSCOPIC

Model Number	7209499
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the arthro-pierce 35 degree up broke when they were going through the tendon and pulling the anchor thread.Surgery was resumed, without any delay with the same device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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 visual inspection of the returned device found that it is not in its original packaging.The distal end of the device is fractured, with the entire end missing.There is some wear to the device but the laser etchings are clear.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).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.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.¿ a complaint history review found similar reported events.¿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.¿ anticipated risk is maintained: 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.¿this case reports, the breakage of the arthro-pierce instrument as it was going through the tendon and pulling the anchor thread.Reportedly, the procedure was resumed using the ¿same device¿.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported cannot be determined and the patient¿s current health is unknown.However, ¿no further complications were reported,¿ and no patient injury has been alleged.Therefore, no further clinical medical assessment can be rendered.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.

• Brand Name: ARTHROPIERCE 35 DEGREE UP
• 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: 15234226
• Report Number: 1219602-2022-01161
• Device Sequence Number: 4655558
• Product Code: NBH
• UDI-Device Identifier: 03596010474544
• UDI-Public: 03596010474544
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2023

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 Model Number: 7209499
• Device Catalogue Number: 7209499
• Device Lot Number: LT705
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 01/20/2023
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 10/13/2022; 01/23/2023
• 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 Age: 25 YR
• Patient Sex: Male