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

Catalog Number 53-27616S

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event 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.

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8958261
• MDR Text Key: 159616952
• Report Number: 0008031020-2019-01234
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540593979
• UDI-Public: 04546540593979
• Combination Product (y/n): N
• PMA/PMN Number: K080667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 80