MAUDE Adverse Event Report: STRYKER GMBH MINI 3.0MM HEADLESS SCREW LENGTH 40MM; SCREW, FIXATION, BONE

Model Number	IH3040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "surgeon inserted 1.15 k-wire down canal of 3rd metacarpal.Screw length was obtained after countersinking drill bit.2.1mm was inserted down canal as far as possible.3.0 10mm mini headless screw was inserted.When screw was halfway down canal, screwdriver was visibly harder to turn.Shortly after, the screw broke mid shaft.Added a plate" total of "120 min surgery time".
Additional Manufacturer Narrative
The reported event could be confirmed, based on the provided x-rays.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.The x-rays provided are very unclear and could not be analyzed.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.
Event or Problem Description
As reported: "surgeon inserted 1.15 k-wire down canal of 3rd metacarpal.Screw length was obtained after countersinking drill bit.2.1mm was inserted down canal as far as possible.3.0 10mm mini headless screw was inserted.When screw was halfway down canal, screwdriver was visibly harder to turn.Shortly after, the screw broke mid shaft.Added a plate" total of "120 min surgery time".

• Brand Name: MINI 3.0MM HEADLESS SCREW LENGTH 40MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10525087
• Report Number: 0008031020-2020-02222
• Device Sequence Number: 3154880
• Product Code: HWC
• UDI-Device Identifier: 07613327362893
• UDI-Public: 07613327362893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: IH3040
• Device Catalogue Number: IH3040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR