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	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that the arthropierce 35 degree broke during surgery when the soft tissues were sutured in the shoulder.A backup device was available to complete the procedure with no significant delay or other complications.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 received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images found that the lower jaw of the device had fractured off.A visual inspection revealed that the distal tip of the device had broken off cleanly.The broken piece was returned in an envelope.There was some wear on the device, but no debris.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.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.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include more frequent use than anticipated for the device, rough sterilization processes, or inability to withstand excessive forces during use.No containment or corrective actions are recommended at this time.

• Brand Name: ARTHROPIERCE 35 DEGREE UP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11526978
• Report Number: 1219602-2021-00570
• Device Sequence Number: 4536794
• Product Code: NBH
• UDI-Device Identifier: 03596010474544
• UDI-Public: 03596010474544
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 7209499
• Device Catalogue Number: 7209499
• Device Lot Number: 50689630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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