MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEGREE LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number	7209498
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).The sample is under evaluation by the manufacturing site.
Event or Problem Description
It was reported that the arthropierce had a missing part.No case reported; therefore, there was no patient involvement.Preliminary results of investigation have concluded that device top jaw sheared off which makes it a reportable event.
Additional Manufacturer Narrative
H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned 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 visual inspection found that the product information is faded and the top of the jaw is sheared off where it meets the actuator.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.

• Brand Name: ARTHROPIERCE 45 DEGREE LEFT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12431236
• Report Number: 1219602-2021-01872
• Device Sequence Number: 3579021
• Product Code: NBH
• UDI-Device Identifier: 03596010474537
• UDI-Public: 03596010474537
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 7209498
• Device Catalogue Number: 7209498
• Device Lot Number: T1605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1