MAUDE Adverse Event Report: STRYKER GMBH CANNULATED COMPRESSION SCREW; PLATE, FIXATION, BONE

Model Number	58-30418
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2020
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
It was reported: the procedure was a scaphoid lunate fusion.The screw was through both carpals and the head (blue part) disengaged from the shaft of the screw during the application of the compression portion of surgery.Case was delayed about 45 mins to an hour.
Event or Problem Description
It was reported: the procedure was a scaphoid lunate fusion.The screw was through both carpals and the head (blue part) disengaged from the shaft of the screw during the application of the compression portion of surgery.Case was delayed about 45 mins to an hour.
Additional Manufacturer Narrative
Correction: refer to d9/h3 device availability.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 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 is unknown.

• Brand Name: CANNULATED COMPRESSION SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10157210
• Report Number: 0008031020-2020-01699
• Device Sequence Number: 3016987
• Product Code: HRS
• UDI-Device Identifier: 04546540362094
• UDI-Public: 04546540362094
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K013775
• 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): 08/12/2020

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: 58-30418
• Device Catalogue Number: 58-30418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR