MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH SCSR STR; ACCESSORIES,ARTHROSCOPIC

Model Number	012036
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case: (b)(4).
Event or Problem Description
It was reported that the punch scsr str were biting at edges.No case reported; therefore, there was no patient involvement.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 device and the reported incident.An analysis of the customer provided images confirmed the part and batch numbers.The device was shown with a thin piece of leather it had been used on to demonstrate its poor cutting capabilities.The device was able to indent the leather, but seemed to be catching rather than fully puncturing through.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 a repeat issue.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include improper sterilization techniques, friction buildup, or material wear from day to day use.

• Brand Name: PCH SCSR STR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11175953
• Report Number: 1219602-2021-00129
• Device Sequence Number: 2270783
• Product Code: NBH
• UDI-Device Identifier: 03596010023728
• UDI-Public: 03596010023728
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 012036
• Device Catalogue Number: 012036
• Device Lot Number: 50884838
• Initial Date Received by Manufacturer: 12/25/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1