MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT SCP UPBTR 1.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	012020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy for knee meniscus, the punch basket broke off in the patient's joint (metal piece of 0.5cm x 1.5cm).X-ray was performed to locate the piece and an additional incision was made on the patient to removed it.It is unknown if a back-up device was available.8 minutes of delay occurred.No further complications reported.
Additional Manufacturer Narrative
H10: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A manufacturing record review could not be conducted as no lot number was provided.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.Insufficient clinical information was provided and a thorough clinical assessment cannot be performed at this time.The patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.A relationship, if any, between the subject device and the reported event could not be determined.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.B5: update description of event.
Event or Problem Description
It was reported that during an arthroscopy for a knee meniscus, the punch basket broke off in the patient's joint (metal piece of 0.5cm x 1.5cm).An x-ray was performed to locate the piece and an additional incision was made on the patient to remove it resulting in a surgical delay of 8 minutes.It is unknown if a back-up device was available.No other complications were reported.Current patient status was reported as ¿good¿.

• Brand Name: PCH BSKT SCP UPBTR 1.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11828574
• Report Number: 1219602-2021-01140
• Device Sequence Number: 1059303
• Product Code: NBH
• UDI-Device Identifier: 03596010023469
• UDI-Public: 03596010023469
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 012020
• Device Catalogue Number: 012020
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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