MAUDE Adverse Event Report: STRYKER GMBH HEADLESS COMPRESSION SCREW FIXOS Ø4.0MM / L42MM; SCREW, FIXATION, BONE

Catalog Number	658042
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
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
It was reported that the head of 4.0 fixos screw broke off during removal from distal tibia.Remainder of screw was retained in patient.No adverse consequences were reported.
Event or Problem Description
It was reported that the head of 4.0 fixos screw broke off during removal from distal tibia.Remainder of screw was retained in patient.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was 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 any further information is provided, the investigation report will be updated.H3 other text : device disposition unknown.

• Brand Name: HEADLESS COMPRESSION SCREW FIXOS Ø4.0MM / L42MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8739907
• Report Number: 0008031020-2019-00750
• Device Sequence Number: 11362271
• Product Code: HWC
• UDI-Device Identifier: 07613252707028
• UDI-Public: 07613252707028
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K133451
• 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): 09/02/2019

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: 658042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 81