MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L32MM; PLATE, FIXATION, BONE

Catalog Number	661032S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
During axsos ti surgery, the drill broke.The patient bone was so hard due to the cancer.The drill fragment was removed from the patient.The locking screw broke when the surgeon checked the screw locking and applied torque to the screw head.The shaft of the screw remained in the patient.
Additional Manufacturer Narrative
The reported event that locking screw axsos 3 ti 4.0mm/l28mm was alleged of issue s-11 (breakage during surgery) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.The device inspection was not possible as the product was not returned for investigation.A review of the device history record 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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
During axsos ti surgery, the drill broke.The patient bone was so hard due to the cancer.The drill fragment was removed from the patient.The locking screw broke when the surgeon checked the screw locking and applied torque to the screw head.The shaft of the screw remained in the patient.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L32MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7068289
• Report Number: 0008031020-2017-00672
• Device Sequence Number: 118777
• Product Code: HRS
• UDI-Device Identifier: 04546540685889
• UDI-Public: 04546540685889
• Combination Product (Y/N): N
• PMA/510(K) Number: K123964
• 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): 01/02/2018

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 Expiration Date: 01/21/2022
• Device Catalogue Number: 661032S
• Device Lot Number: L03615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR