MAUDE Adverse Event Report: MEDCAD ACCUPLAN; SURGICAL GUIDE

Model Number	MC-K011
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On may 5, 2022 medcad was notified by a distributor sales representative that the patient matched accuplan surgical guide did not appear to fit the patient at the time of surgery.The guide was reportedly unable to be used during the procedure.When asked whether the malfunction impacted the outcome of the procedure, the sales representative stated, "it all worked out thankfully." there was no indication of patient harm as a result of this deficiency.Upon review of the guide design that was produced for the patient, it was determined that the guide had been mistakenly designed according to the anatomy of a different patient.The operator responsible for the error stated in an interview that he had mistakenly exported the incorrect design file when transferring the work order to manufacturing.Investigation concluded that a mixup during production caused the guide for this case to be designed according to the incorrect patient's anatomy.
Event or Problem Description
The patient matched surgical guide did not fit the patient at the time of surgery.

• Brand Name: ACCUPLAN
• Common Device Name: SURGICAL GUIDE
• Manufacturer (Section D): MEDCAD; 501 south second ave.; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 south second ave.; suite a1000; dallas TX 75226
• Manufacturer Contact: james allo ; 501 south second ave.; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 14595421
• Report Number: 3009196021-2022-00005
• Device Sequence Number: 4832471
• Product Code: DZJ
• UDI-Device Identifier: 00810007630366
• UDI-Public: (01)00810007630366(10)226789SER
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: MC-K011
• Device Catalogue Number: MC-K011
• Device Lot Number: 226789SER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 54 KG