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

Catalog Number	656414S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported the following: "when inserting the screw into the bone, at the start of tightening, the screw (head) spontaneously broke off.It was removed and replaced.Actions: screw removed then replaced.Financial loss + increased operating time.".
Event or Problem Description
The customer reported the following: "when inserting the screw into the bone, at the start of tightening, the screw (head) spontaneously broke off.It was removed and replaced.Actions: screw removed then replaced.Financial loss + increased operating time.".
Additional Manufacturer Narrative
Please note correction to d9 (product available to stryker).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.No indications of material or manufacturing related problems were found during the investigation.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported the following: "when inserting the screw into the bone, at the start of tightening, the screw (head) spontaneously broke off.It was removed and replaced.Actions: screw removed then replaced.Financial loss + increased operating time.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: screw was received with a broken head.The recess of the screw shows significant deformation marks in clockwise direction which indicates excess torque being applied to the screw while tightening which most probably led to the snapping of screw head intra-operatively.The first thread in the shaft below the broken head is also plastically deformed, however, it cannot be confirmed whether this happened during screw insertion or extraction.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.No indications of material or manufacturing related problems were found during the investigation.Based on investigation, the root cause was attributed to a usage related issue.The event was caused by over torquing the screw while tightening.If any additional information is provided, the investigation will be reassessed.

• 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
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22375913
• Report Number: 0008031020-2025-01035
• Device Sequence Number: 4413526
• Product Code: HWC
• UDI-Device Identifier: 07613327070873
• UDI-Public: (01)07613327070873(17)291210(10)1000583904
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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 Catalogue Number: 656414S
• Device Lot Number: 1000583904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 01/19/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/25/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 52 KG