MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW AXSOS 3 TI 4.0MM / L30MM / FULL THREAD; PLATE, FIXATION, BONE

Model Number	607330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Screw head discarded by hospital; screw shaft remains in situ.
Event or Problem Description
It was reported that while inserting one 4.0 x 30 mm cancellous screw full thread on the axsos 3 tibia plate, the screw head broke.The body of the screw remains in patient's body.No adverse consequences to the patient or clinically significant surgical delay were reported.
Event or Problem Description
It was reported that while inserting one 4.0 x 30 mm cancellous screw full thread on the axsos 3 tibia plate, the screw head broke.The body of the screw remains in patient's body.No adverse consequences to the patient or clinically significant surgical delay were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.The optech instructs user that: ¿locking screws of appropriate length are inserted into the plate using the t15 screwdriver.If inserting locking screws under power using the t15 screwdriver bit, make sure to use a low speed drill setting to avoid damage to the screw plate interface and potential thermal necrosis.In hard bone, it is advised to use the locking tap ø4.0mm before screw insertion.Caution: always perform final tightening of the locking screws by hand using the 2.5nm torque limiter together with the screwdriver bit t15 and t-handle.This prevents overtightening of locking screws and also ensures that these screws are properly tightened with a torque of 2.5nm.The device will click when the torque reaches 2.5nm.This procedure is repeated for all locking screws.¿ 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 per additional information provided, one of the probable causes of failure is not using the torque limiter to implant the screws.The optech instructs user ¿always perform final tightening of the locking screws by hand using the 2.5nm torque limiter together with the screwdriver bit t15 and t-handle.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: CANCELLOUS SCREW AXSOS 3 TI 4.0MM / L30MM / FULL THREAD
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12202262
• Report Number: 0008031020-2021-00314
• Device Sequence Number: 4441072
• Product Code: HRS
• UDI-Device Identifier: 07613252578536
• UDI-Public: 07613252578536
• Combination Product (Y/N): N
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 607330
• Device Catalogue Number: 607330
• Device Lot Number: D61267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 100