MAUDE Adverse Event Report: STRYKER GMBH MINI 2.5MM HEADLESS SCREW LENGTH 40MM; SCREW, FIXATION, BONE

Model Number	IH2540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
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 discarded.
Event or Problem Description
Doctor performed a femoral head orif.While he was inserting a 2.5x40 headless stryker mini screw, the screw broke off leaving half of it in the patient¿s bone.Also, while he was inserting a 3.0x40 headless stryker mini screw the screw bent so it was not able to inserted.Added time to the surgery (5-10 minutes).Additionally reported: the surgeon switched to using 3.5 non-locking screws from the variax 2 core tray to finish the surgery.
Event or Problem Description
Doctor performed a femoral head orif.While he was inserting a 2.5x40 headless stryker mini screw, the screw broke off leaving half of it in the patient¿s bone.Also, while he was inserting a 3.0x40 headless stryker mini screw the screw bent so it was not able to inserted.Added time to the surgery (5-10 minutes).Additionally reported: the surgeon switched to using 3.5 non-locking screws from the variax 2 core tray to finish the surgery.
Additional Manufacturer Narrative
Correction: refer to h6 method, results & conclusion codes.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Since x-rays were provided, the opinion of a medical expert was requested.His statement is as follows: " [.] these type of fracture usually occur in young patients and are most commonly caused by high energy trauma.First of all i would consider this to be off label use (crba mini screws, indication statement does not include femoral head) [.]" indeed, the devices are not indicated for the fractures of the femoral head.Therefore, based on investigation, the root cause was attributed to be user related.The failure was caused by off label use of the product.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: MINI 2.5MM HEADLESS SCREW LENGTH 40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11008063
• Report Number: 0008031020-2020-02554
• Device Sequence Number: 14439289
• Product Code: HWC
• UDI-Device Identifier: 07613327362633
• UDI-Public: 07613327362633
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120493
• 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
• Report Date (Section B): 03/26/2021

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 Model Number: IH2540
• Device Catalogue Number: IH2540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1