MAUDE Adverse Event Report: STRYKER GMBH CANNULATED LOW COMPRESSION SCREW AUTOFIX Ø2.0 X 24MM; SCREW, FIXATION, BONE

Catalog Number	1412024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The following event was reported by the hospital: "right osteosynthesis on (b)(6) 2019 and during postoperative immobilization radiographic check-up at one month postoperatively, broken osteosynthesis screw was observed.Clinical consequence: postoperative immobilization.Action taken: re-intervention scheduled today.
Additional Manufacturer Narrative
Correction: the reported event could be confirmed, as the device was returned and presented a breakage at the very end of its thread.More information is needed (such as x-rays, patient activity level.) in order to point out the actual reason for the screw breakage.However, most likely the factors that led to such an event are the following: inadequate surgery technique putting two screws in contact, the operative technique clearly states "note: pay attention to not put the two screws in contact.Two screws touching each other can lead to screw damage / failure due to excessive screwing torque and could generate unexpected metal fragments." a second reason could be that the patient was not compliant, the instruction for use clearly mentions that: " the implant can fail due to excessive load, wear and tear, or infection.The service life of the implant is determined by body weight and physical activity.The implant must not be subjected to overload too early through extreme strain, or through work-related or athletic activities.A third reason that could lead to the screw breakage is an inadequate bone quantity and/or bone quality, the instruction for use highlights the contraindications: do not use the autofix system in cases of: osteopenic bone.Inadequate bone quantity and/or bone quality ".Therefore based on the following reasons, this case is classified as a user or patient related.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The following event was reported by the hospital: "right osteosynthesis on (b)(6) 2019 and during postoperative immobilization radiographic check-up at one month postoperatively, broken osteosynthesis screw was observed.Clinical consequence: postoperative immobilization.Action taken: re-intervention scheduled today.

• Brand Name: CANNULATED LOW COMPRESSION SCREW AUTOFIX Ø2.0 X 24MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8449767
• Report Number: 0008031020-2019-00309
• Device Sequence Number: 1465412
• Product Code: HWC
• UDI-Device Identifier: 03700586900837
• UDI-Public: 03700586900837
• 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): 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 1412024
• Device Lot Number: Q0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 80