MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X 4MM PROFILE ZERO AUTODRIVE SCREW; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Model Number	218-1604
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently pending.A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
During the cranioplasty procedure on (b)(6) 2022, the physician was implanting screws (part number 218-1604) into a profile zero square plate.When the screw head interfaced with the plate, the screw "slipped" right through the plate hole and into the bone.It was reported it appeared as if the screw heads were smaller than the plate holes.This issue occurred with several screws as a plate the surgeon thought was secure "lifted" up leaving the screws in the bone and unattached to the plate.The 218-1604 screws were removed and replaced with part number 218-1605 screws which secured the plate flush to the bone with no issues.It was reported the five (5) 218-1604 screws involved in this event are being returned for evaluation.This report is related to report numbers 2207754-2022-00031, 2207754-2022-00033, 2207754-2022-00034, and 2207754-2022-00035 for the other screws involved in this event.
Additional Manufacturer Narrative
Five (5) screws were received for evaluation.Quality control assessed the screw head diameter on the five (5) returned parts based on the complaint description of the screw falling through the plate.All five (5) screw heads were within specification.A 2-year review of the complaints database revealed no other complaints for this issue with this part number.Based on the information received and the investigation performed, the root cause could not be determined.

• Brand Name: 1.6MM X 4MM PROFILE ZERO AUTODRIVE SCREW
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 14640754
• Report Number: 2027754-2022-00032
• Device Sequence Number: 20276460
• Product Code: GWO
• UDI-Device Identifier: 00845694034258
• UDI-Public: (01)00845694034258(10)1170273(30)1(11)220519
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K111176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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: 218-1604
• Device Catalogue Number: 218-1604
• Device Lot Number: 1170273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White