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

Model Number 012036

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during a knee arthroscopy, the fixed part of a punch scissor straight loop handle broke off while in use inside the patient.Surgery was resumed, without any delay, with the same device.The patient had to undergo a second surgery to have the item that broke off removed.Current health status of the patient is stable.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was 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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition was reported as stable.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Correction in d4.

• Brand Name: PCH SCSR STR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14080302
• MDR Text Key: 289061654
• Report Number: 1219602-2022-00519
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010023728
• UDI-Public: 03596010023728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 012036
• Device Catalogue Number: 012036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female