MAUDE Adverse Event Report: STRYKER GMBH HEADLESS COMPRESSION SCREW FIXOS II Ø4.0MM / L40MM; SCREW, FIXATION, BONE

Model Number	658040
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "i had a sales rep that called me in the last week and reported that he had a fixos 2 screw that the threads ribboned as it was being inserted.The screw was put in on power and when the tip of the screw was drilled it peeled out in to numerous pieces, there was no shank left on the screw.The surgeon was unable to get the screw out of the patient, successful compression was not achieved.This created a 20-minute delay in the case.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : the device remains implanted in the patient.
Additional Manufacturer Narrative
The reported event could be confirmed based on the evidence received.The evidence inspection revealed the following: x-rays were received for inspection.The stripping of the screw could be confirmed.However, with only the ap view available, it was not possible to determine the exact circumstances under which the fragmentation occurred.The device as well as x-rays of the lateral view would have given further information and would have been necessary in order to determine the root cause of the event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "i had a sales rep that called me in the last week and reported that he had a fixos 2 screw that the threads ribboned as it was being inserted.The screw was put in on power and when the tip of the screw was drilled it peeled out in to numerous pieces, there was no shank left on the screw.The surgeon was unable to get the screw out of the patient, successful compression was not achieved.This created a 20-minute delay in the case.

• Brand Name: HEADLESS COMPRESSION SCREW FIXOS II Ø4.0MM / L40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16935478
• Report Number: 0008031020-2023-00191
• Device Sequence Number: 12606503
• Product Code: HWC
• UDI-Device Identifier: 07613252706991
• UDI-Public: 07613252706991
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133451
• 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): 07/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 658040
• Device Catalogue Number: 658040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown