MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES KIT: STAPLE REMOVER

Model Number	82360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident 4 of 5.Medical action industries is the manufacturer of the staple removal kit.The complaint component, staple remover part number s6410pt is manufactured by fine surgical, inc.(fda registration 2433092).A supplier corrective action (scar) was submitted to the manufacturer on 23aug2022.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or caused serious injury.
Event or Problem Description
Mai complaint number (b)(4).Incident four: the staple remover is breaking the staples when trying to remove them from patients.Staples either become difficult to remove or a piece flies through the air.On one occasion, staple hit nurse in face.This was identified during use.No injury, medical treatment, or delay in procedure was reported to have occurred as a result of incident.
Additional Manufacturer Narrative
Incident four: we received a photo of the staple removed from the incident and three samples from the customer; one from the actual incident in a biohazard bag and two unopened kits.We immediately sent the samples to our supplier for their examination.The device history record of the complaint kit lot was reviewed with no nonconformances involving this instrument during production.A review of our trending database shows this is our first complaint for this kit.The component lots involved were placed in various kit lots with no additional reports of this nature from other customers.Based on trending analysis, this complaint was determined to be isolated.The supplier stated that after examination of the customer¿s three returned samples, they all met product and rivet measurement specifications, did not appear to have any malfunctioning parts.The supplier has noted the instrument may be sensitive to end-user technique, cold rolled steel instrument can flex, coupled with user possibly twisting instrument during staple removal.In this case, the staple may break instead of bending.The supplier has performed machine adjustments to tighten the rivets of the instrument to enhance the functions of the movement.The supplier has increased inspection with revised sampling plan and re-trained employees.Several recent shipments passed all inspections after these actions were implemented.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or caused serious injury.

• Brand Name: KIT: STAPLE REMOVER
• Common Device Name: KIT: STAPLE REMOVER
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17346146
• Report Number: 1030451-2023-00011
• Device Sequence Number: 20470020
• Product Code: KDD
• UDI-Device Identifier: 10809160370490
• UDI-Public: 10809160370490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 82360
• Device Catalogue Number: 82360
• Device Lot Number: 300270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown