MAUDE Adverse Event Report: I.T.S. GMBH CORTICAL STABILIZATION SCREW, D=3.0MM, L=14MM, RH

Model Number	37304-14
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After starting investigation we could find the correct article and lot number of the broken screw due to the shipping documents to the hospital and the re-stock orders.The device history record (dhr) of the affected screw were inspected and showed no deviations.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.As a result of the above and the fact that no device was returned for evaluation, this complaint is deemed unconfirmed.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that a locking screw broke intra-operatively.Original implanted date (b)(6) 2019.Further information like article and lot number not provided.

• Brand Name: CORTICAL STABILIZATION SCREW, D=3.0MM, L=14MM, RH
• Common Device Name: CORTICAL STABILIZATION SCREW, D=3.0MM, L=14MM, RH
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 8756582
• Report Number: 3004369035-2019-00008
• Device Sequence Number: 1489459
• Product Code: HWC
• UDI-Device Identifier: 09120047295090
• UDI-Public: 09120047295090
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K130008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 37304-14
• Device Catalogue Number: 37304-14
• Device Lot Number: 86/483337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other