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

Catalog Number	53-27616S
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by the pharmacy to the general manager that on (b)(6) 2019, doctor reported an incident to (b)(6) concerning a stryker screw with the following event: "when a self-tapping screw was screwed onto the plate, the head broke and the screw body remained in a place without being able to remove it.I got the screws and the head back.There was a longer intervention due difficulties in removing the broken screw.
Event or Problem Description
It was reported by the pharmacie to the general manager that on (b)(6) 2019, doctor reported an incident to the ansm concerning a stryker screw with the following event: "when a self-tapping screw was screwed onto the plate, the head broke and the screw body remained in a place without being able to remove it.I got the screws and the head back.There was a longer intervention due difficulties in removing the broken screw.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided, despite multiple attempts.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 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.H3 other text : device disposition unknown.

• 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: 8600940
• Report Number: 0008031020-2019-00415
• Device Sequence Number: 11347790
• Product Code: HRS
• UDI-Device Identifier: 04546540593979
• UDI-Public: 04546540593979
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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 Catalogue Number: 53-27616S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1