MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A3219, SHORT HANDLE, SZ 3-40 DEG CLAMP; CLAMP, VASCULAR

Model Number	A3219
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: cags.[name] was scrubbed for the case one of the clamps that has the inserts that they put on the jaws.[name] applied the inserts to the jaws and did one click of the ratchet as she normally does and put it on her mayo.When she went to give it to the surgical team they noticed that the ratchet wasn¿t working.They looked at the box joint of the clamp and noticed a fracture through one of the arms.This same issue has happened in january with another 1 of 6 clamps that were purchased at the same time.Intervention: ni.Patient status: patient is fine, and completely unaffected.
Event or Problem Description
Procedure performed: cags.[name] was scrubbed for the case one of the clamps that has the inserts that they put on the jaws.[name] applied the inserts to the jaws and did one click of the ratchet as she normally does and put it on her mayo.When she went to give it to the surgical team they noticed that the ratchet wasn¿t working.They looked at the box joint of the clamp and noticed a fracture through one of the arms.This same issue has happened in january with another 1 of 6 clamps that were purchased at the same time.Intervention: ni.Patient status: patient is fine, and completely unaffected.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the box lock of the returned unit was fractured.Corrosion was also observed around the location of the break.Based on the condition of the returned unit, the fracture was caused by the corrosion that was observed around the location of the break.Reusable devices are designed to withstand repeated use and sterilization cycles.However, the lifespan of the device is dependent on the storage, cleaning, and usage conditions.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: A3219, SHORT HANDLE, SZ 3-40 DEG CLAMP
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11642445
• Report Number: 2027111-2021-00440
• Device Sequence Number: 16893722
• Product Code: DXC
• UDI-Device Identifier: 00607915114244
• UDI-Public: (01)00607915114244(11)180614(30)01(10)1327756
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A3219
• Device Catalogue Number: 100607001
• Device Lot Number: 1327756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/09/2021
• 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