MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Model Number	656418S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head sheared off the screw and the threads were left in situ in the patient.Additional information received: the procedure could be completed successfully.Delay of 5 mins whilst trying to retrieve broken part of screw.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device can not be returned as it is contaminated.
Additional Manufacturer Narrative
Please note the correction to h6 device code.The reported event could be confirmed, since we received two pictures for evaluation and they match the alleged failure mode.The device inspection revealed the following: we have received two pictures of the head¿s screw that was sheared off the screw.The received pictures of the screw was found to be broken from the head region.Since these are pictures taken with a camera, we cannot analyze in depth as with a microscope nor confirm the cat# and the lot# of the device.This type of failure is typical of that caused by torsional and bending overload.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was primarily attributed to be user related along with patient factor such as hard/dense bone.The breakage was caused due to application of slightly high force.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the head sheared off the screw and the threads were left in situ in the patient.Additional information received: the procedure could be completed successfully.Delay of 5 mins whilst trying to retrieve broken part of screw.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15326395
• Report Number: 0008031020-2022-00420
• Device Sequence Number: 5375242
• Product Code: HWC
• UDI-Device Identifier: 07613327070897
• UDI-Public: 07613327070897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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 Expiration Date: 06/29/2025
• Device Model Number: 656418S
• Device Catalogue Number: 656418S
• Device Lot Number: 1000410238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• 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 Sex: Unknown