MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM X 5MM AUTO-DRIVE SCREW; SCREW, FIXATION, BONE

Model Number	211-1605
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not received for evaluation.A review of manufacturing and inspection records could not be performed as device batch/lot number was not provided.Should the device be returned, a follow up report will be submitted upon completion of the investigation.
Event or Problem Description
During a frontal cranioplasty procedure on (b)(6) 2022, it was reported that the heads of two (2) screws broke.The stems of the screws were removed from the patient and new screws were inserted.There were no adverse consequences to the patient, and the procedure was delayed by "only a few minutes." this report is related to report number 2027754-2022-00029 which is for the other screw involved in this event.
Additional Manufacturer Narrative
Additional information received: a2: only year given for date of birth as 1997.Estimated age is 25 years.A4: patient weight 165ibs, d4: lot number provided as 1166672.
Additional Manufacturer Narrative
Broken fragments of the reported screws were returned for evaluation.Manufacturing and inspection records were reviewed and no anomalies were noted.Based on the information provided and the investigation performed, the root cause could not be determined.The instructions for use states ""use of an undersized screw or plate in areas of high functional stresses may lead to implant fracture and failure", "use of screws in high density bone may lead to implant fracture or failure upon insertion", "use of excessive torque during insertion of screws may lead to implant failure".

• Brand Name: 1.6MM X 5MM AUTO-DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 14605674
• Report Number: 2027754-2022-00028
• Device Sequence Number: 20125006
• Product Code: HWC
• UDI-Device Identifier: 00845694002370
• UDI-Public: (01)00845694002370(10)1166672(30)1(11)220201
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K974785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2022

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: 211-1605
• Device Catalogue Number: 211-1605
• Device Lot Number: 1166672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 08/04/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/22/2022; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic