MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.4MM/L16MM; SCREW, FIXATION, BONE

Model Number	656116S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient had orthopaedic surgery.Staff commented post surgery that surgery guides were loose.Therefore radiological scan was performed and an examination of the scan showed that retained object looked to be a screw head of aprox 2.4mm diameter.Identified that screw was from the stryker variax2 bone screw used during operation.Surgeon reopened operation site, but could not locate metal piece.Decision was made to leave it as exploratory surgery would cause more harm".
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 in a supplemental report.H3 other text : device remains implanted.
Event or Problem Description
As reported: "patient had orthopaedic surgery.Staff commented post surgery that surgery guides were loose.Therefore radiological scan was performed and an examination of the scan showed that retained object looked to be a screw head of aprox 2.4mm diameter.Identified that screw was from the stryker variax2 bone screw used during operation.Surgeon reopened operation site, but could not locate metal piece.Decision was made to leave it as exploratory surgery would cause more harm.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation.However, a post-op x-ray was provided but is not sufficient to reach any conclusion.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.An x-ray was provided which was presented to our health care professional for evaluation, and a question about the most likely reason for this event and harm associated with it was asked, to which the medical expert replied: ¿the metal part looks small, although there is only one x-ray to make this call on.I can also not judge where the debris is located in the arm, intramuscular? or superficial? usually the body encapsules these fragments, and they cause no harm.In a worst case, the sharp ends (if there are any) may cause pain and or inflammation, migration of the part could occur in rare cases.¿ from the provided x-ray it is unclear that what broke off, or what stayed behind.Neither we can say that the circular ring we see in x-ray is apart of implant or instrument debris.X-ray's in different views and 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.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.4MM/L16MM
• 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: 16918265
• Report Number: 0008031020-2023-00179
• Device Sequence Number: 17843869
• Product Code: HWC
• UDI-Device Identifier: 07613327070538
• UDI-Public: 07613327070538
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: Lay User/Patient
• Device Model Number: 656116S
• Device Catalogue Number: 656116S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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