MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Model Number	656414S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
The customer reported that the 2.7 variax cortical screw broke after being put through a plate during a distal orif case.The surgeon had to leave the broken screw in as it would cause more trouble taking it out.
Additional Manufacturer Narrative
The reported event could be confirmed, though the product was not returned for evaluation, but the images and event matches the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, as indicated in the communication; the bone quality good & taking into consideration it was pre drilled.The probable root cause would be but not limited to; patient factor (hard/dense bone), or predominantly user related (e.G.Position/ angle of implant is incorrect, mislocking over tightening or too high force application) etc.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The customer reported that the 2.7 variax cortical screw broke after being put through a plate during a distal orif case.The surgeon had to leave the broken screw in as it would cause more trouble taking it out.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10855957
• Report Number: 0008031020-2020-02481
• Device Sequence Number: 910231
• Product Code: HWC
• UDI-Device Identifier: 07613327070873
• UDI-Public: 07613327070873
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 07/08/2025
• Device Model Number: 656414S
• Device Catalogue Number: 656414S
• Device Lot Number: 1000411901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1