MAUDE Adverse Event Report: STRYKER GMBH CANNULATED LOW COMPRESSION SCREW AUTOFIX 2.0 X 22MM; SCREW, FIXATION, BONE

Model Number	141-2022
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	07/07/2020
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
Customer reported that : "during the installation of two autograde septoid screws without stress on the installation, fracture of the distal thread and bursting of the 2 screws.Persistence of metal in the proximal area of the scaphoid, need to place another material." additionally reported: 30 minute surgical delay, impossible to remove the thread because it has expanded into the bone and there is a danger of damaging the proximal pole of the scaphoid.
Additional Manufacturer Narrative
The reported event could be confirmed.The most likely cause is that the surgeon put two screws in contact.The collision led to thread detachment and following breakage.Autofix operative technique warns about this possibility and explicitly states not to put two screws in contact.The manufacturer is not responsible for any complications arising from incorrect operating techniques.Other possible root causes are: - the integrity of the screw had not been verified prior to use.- the screw has been used more than once.Previous stresses created non-visible damages which led to implant breakage during surgery.- the package of the screw was damaged and the device has been used anyway.The damage of the package compromised the implant integrity and led to implant breakage during surgery.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.Based on investigation, the root cause was attributed to be user related.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer reported that : "during the installation of two autograde septoid screws without stress on the installation, fracture of the distal thread and bursting of the 2 screws.Persistence of metal in the proximal area of the scaphoid, need to place another material." additionally reported: - 30 minute surgical delay - impossible to remove the thread because it has expanded into the bone and there is a danger of damaging the proximal pole of the scaphoid.

• Brand Name: CANNULATED LOW COMPRESSION SCREW AUTOFIX 2.0 X 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10370109
• Report Number: 0008031020-2020-02080
• Device Sequence Number: 11517561
• Product Code: HWC
• UDI-Device Identifier: 03700586900820
• UDI-Public: 03700586900820
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052576
• 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): 11/10/2020

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: 141-2022
• Device Catalogue Number: 1412022
• Device Lot Number: 87167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1