MAUDE Adverse Event Report: GUIDEWIRE 1.5 X 229 (9 ); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202810
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the plastic tips on end of the guidewire seemed almost melted on and it could not get off.A scalpel was used to removed it.Incident occurred while setting-up to the procedure.A back-up device was available and no significant delay occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the drawing found that the silicone tip protectors have been changed to plastic sleeves since the manufacture of this device.The change was implemented due to customer feedback that the silicone tip protectors were difficult to remove.A visual inspection found a guide wire with damaged rubber safety caps melted on the tips.The complaint was confirmed and the root cause was associated with device design.No containment or corrective actions are recommended at this time.

• Brand Name: GUIDEWIRE 1.5 X 229 (9 )
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• MDR Report Key: 11646793
• Report Number: 1219602-2021-00843
• Device Sequence Number: 3097828
• Product Code: LXH
• UDI-Device Identifier: 00885554000207
• UDI-Public: 00885554000207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2021

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 Expiration Date: 11/30/2022
• Device Model Number: 72202810
• Device Catalogue Number: 72202810
• Device Lot Number: 50699981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 11/02/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 05/06/2021; 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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