MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T7, 2.7X16MM; PLATE, FIXATION, BONE

Catalog Number	53-27616S
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The patient underwent an osteosynthesis using vadr on (b)(6) 2019.During surgery, the screw head broke off when the surgeon tighten the screw to the screw hole of the shaft bone.The patient bone was hard.The screw shaft that loss of the head could not be removed from the patient, it was remained as it is.
Additional Manufacturer Narrative
The reported event 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.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, manufacturing or design related problems were found during the investigation.If the device is found or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient underwent an osteosynthesis using vadr on (b)(6) 2019.During surgery, the screw head broke off when the surgeon tighten the screw to the screw hole of the shaft bone.The patient bone was hard.The screw shaft that loss of the head could not be removed from the patient, it was remained as it is.

• Brand Name: LOCKING SCREW, T7, 2.7X16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8958261
• Report Number: 0008031020-2019-01234
• Device Sequence Number: 19479245
• Product Code: HRS
• UDI-Device Identifier: 04546540593979
• UDI-Public: 04546540593979
• Combination Product (Y/N): N
• PMA/510(K) Number: K080667
• 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): 11/22/2019

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: 11/28/2023
• Device Catalogue Number: 53-27616S
• Device Lot Number: 1000329918
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 80