MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L36MM; PLATE, FIXATION, BONE

Catalog Number	614636
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/15/2019
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
It was back out that the most distal screw of the at the postoperative x - ray.As surgeon's comment, it is not that the angle of the screw was overturned too much but only that one was not locked.The screw was removed and the screw was reinserted as revision surgery.
Event or Problem Description
It was back out that the most distal screw of the at the postoperative x - ray.As surgeon's comment, it is not that the angle of the screw was overturned too much but only that one was not locked.The screw was removed and the screw was reinserted as revision surgery.
Additional Manufacturer Narrative
The reported event that locking screw variax full thread 3.5mm / l36mm was alleged of issue s-90 (additional/revision procedure) could not be confirmed, since the x-rays confirming the back out of locking screw were not provided for inspection.Visual inspection of the received locking screw shows traces of use.No further visual damage was observed.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.The ifu instructs that: ¿locking screws should not be used in the oblong holes of the plate.[¿] using the screwdriver blade and the handle, insert the screws until the head is properly seated in the hole.If power insertion is used, it must be used at low speed.¿ based on investigation, the root cause was attributed to a user related issue.According to event description screw was not locked properly.Design of locking screw provides extra threads along the periphery of the screw head, which engages with hole threads of the variax plate.Insufficient locking of the screw could have caused back out of locking screw post-operatively.If any further information is provided, the investigation will be updated accordingly.
Event or Problem Description
It was back out that the most distal screw of the at the postoperative x - ray.As surgeon's comment, it is not that the angle of the screw was overturned too much but only that one was not locked.The screw was removed and the screw was reinserted as revision surgery.Additional information: ¿the angle of the screw had not been overturned too much and the screw had been locked initially.But at the postoperative x-ray, it was found out that the only distal screw was not locked.¿.
Additional Manufacturer Narrative
The reported event that locking screw variax full thread 3.5mm / l36mm was alleged of issue s-90 (additional/revision procedure) could not be confirmed, since the x-rays confirming the back out of locking screw were not provided for inspection.Visual inspection of the received locking screw shows traces of use.The thread flanks of the locking screw were found to be as intended.Material deformation was not observed.No further visual damage was observed.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.The ifu instructs that: ¿locking screws should not be used in the oblong holes of the plate.The compression mechanism starts at the proximal end of the hole and provides 1mm of compression.It is important to note that if the distal oblong hole is to be used as an adaptation hole, it may not be used later as a compression hole since the screw may not be positioned correctly to apply compression.[¿] using the screwdriver blade and the handle, insert the screws until the head is properly seated in the hole.If power insertion is used, it must be used at low speed.¿ based on investigation, the root cause was attributed to a user related issue.Design of locking screw provides additional threads along the periphery of the screw head, which engages with hole threads of the variax plate.Possible cause of failure could be due to too little insertion torque/too short screw implantation, no final tightening of screws etc.If any further information is provided, the complaint report will be updated.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L36MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8329630
• Report Number: 0008031020-2019-00064
• Device Sequence Number: 1650336
• Product Code: HRS
• UDI-Device Identifier: 07613154969869
• UDI-Public: 07613154969869
• Combination Product (Y/N): N
• PMA/510(K) Number: K101056
• 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,Followup
• Report Date (Section B): 04/05/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 614636
• Device Lot Number: Y02730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 04/04/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/01/2019; 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention