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

Model Number	7209497
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that upper movable branch of the arthro-pierce was broken.Incident occurred before the procedure.There was no delay and a back-up device was available.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, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.The customer provided images confirmed the upper branch of the arthropierce was broken.A review of the device history 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.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.The customer provided images confirmed the upper branch of the arthropierce was broken.A review of the device history 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.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.
Additional Manufacturer Narrative
H10, 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.The costumer provided images confirmed the upper branch of the arthropierce was broken.A visual inspection revealed that the upper jaw of the device had broken off.There was significant wear on the handles and indications of age, 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.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 45 DEG RIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10944440
• Report Number: 1219602-2020-01982
• Device Sequence Number: 3189397
• Product Code: NBH
• UDI-Device Identifier: 03596010474520
• UDI-Public: 03596010474520
• 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,Followup,Followup
• Report Date (Section B): 04/15/2021

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: 7209497
• Device Catalogue Number: 7209497
• Device Lot Number: 50619166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 12/30/2020; 04/14/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/04/2021; 01/05/2021; 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1