MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH STNGRY R; ACCESSORIES,ARTHROSCOPIC

Model Number	012058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the basket punch was broken.It is unknown whether there was a back up available or delay in the case and if the event happened during surgery.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: g4, h2, 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 visual inspection was performed on the returned device and revealed a missing set screw.A functional evaluation revealed the device does not actuate due to the missing set screw.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 maintenance.Factors that could have contributed to the reported event include repeatedly rough sterilization processes or lack of functional tests after sterilization to verify complete assembly.

• Brand Name: PCH STNGRY R
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11033036
• Report Number: 1219602-2020-02083
• Device Sequence Number: 13714844
• Product Code: NBH
• UDI-Device Identifier: 03596010024237
• UDI-Public: 03596010024237
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 012058
• Device Catalogue Number: 012058
• Device Lot Number: 2601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1