MAUDE Adverse Event Report: STRYKER GMBH DR IMPLANT KIT, NARROW SHORT LEFT VARIAX2 XPRESS 56MM; PLATE, FIXATION, BONE

Model Number 991053S

Device Problems Positioning Failure (1158); Material Fragmentation (1261); Difficult to Insert (1316)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The surgeon was using a variax2 dr implant kit together with an ordinary instrument kit.When inserting a locking screw, he experienced that the screw would not engage in the plate and some metal chips were detected.They kept the plate in place and used other screws in the plate.

Manufacturer Narrative

Correction: refer to d10/h3 - device not returned.H6 patient, device, and method codes.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were 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 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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.

Event Description

The surgeon was using a variax2 dr implant kit together with an ordinary instrument kit.When inserting a locking screw, he experienced that the screw would not engage in the plate and some metal chips were detected.They kept the plate in place and used other screws in the plate.

• Brand Name: DR IMPLANT KIT, NARROW SHORT LEFT VARIAX2 XPRESS 56MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9747382
• MDR Text Key: 193407937
• Report Number: 0008031020-2020-00512
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327314588
• UDI-Public: 07613327314588
• Combination Product (y/n): N
• PMA/PMN Number: K162841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 991053S
• Device Catalogue Number: 991053S
• Device Lot Number: L34324
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1