• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREW, T7 DIAM.2.3X18MM PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER LEIBINGER FREIBURG LOCKING SCREW, T7 DIAM.2.3X18MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 53-23618E
Device Problems Bent (1059); Break (1069); Malposition of Device (2616)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/15/2017
Event Type  malfunction  
Manufacturer Narrative
The failure mode could be confirmed: the returned screw is very slightly bent. Furthermore this issue is related to investigation pr 1617046. This screw was tried to be inserted after the first screw broke. As far as we understand, the same hole was used for the second screw (this investigation). It was reported that a right plate was implanted on a left wrist. The provided x-ray image further shows that the angle of the remaining part of the broken screw as well as the second screw is not in the allowed 30° cone required for locking. The angle is much larger than the allowed 15°. It could be that large angle is related to the usage of the wrong plate, i. E. A plate that did not fit nicely. The optech "vax-st-1-en rev 0 variax dr optech" states: "smartlock polyaxial drill guide ((b)(4)) allows for ±15 degrees of custom angulation and may be used for more complex fractures. A lip on the drill sleeve will engage and allow toggling in the hole. The range in which the drill guide toggles will create a 30-degree cone and every angle in this range will be a locking position. This may allow the surgeon to aim where the screw/peg should be placed. Also, depending on the placement of the plate, there may be a need to angle a screw/peg out of the fracture line. Note: using one of the provided drill guides for screw hole preparation is mandatory. Not using a drill guide may lead to drilling out of specified locking range and compromise the locking capabilities. " [original statements]" the ifu (b)(4) was reviewed: "the correct selection of the product is extremely important. The product should be used in the correct anatomic location, consistent with accepted standards for internal fixation. Failure to use the appropriate product for the application may result in a premature clinical failure. Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending or fracturing of the product and/or bone. " "placement of all locking screws requires the use of the locking drill guide (62-51723) to ensure proper screw placement. If a drill guide is not used, the screw may not lock into the plate. " if placing a bone screw in a locking hole it requires the use of the locking drill guide ((b)(4)) to ensure proper screw placement. The angle of the inserted screw may not exceed 10°. " "screws should not be over-tightened during insertion. Excessive over-tightening will compromise the integrity of the screw head, result in possible screw breakage, and lead to loss of friction fit performance. " [original statements]: possible root causes among others are: using the wrong plate, not using drill guides for hole preparation, applying too high torques. In summary, we conclude that the reported failure is most likely a user error and not a product failure. 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 Description
A distal radius variax plate was fixed to a patient. The most proximal screw went skew through the plate and was then snapped against the furthest cortex. The head of the screw could be removed, the other part is still in the patient's bone. There was a surgical delay of 15 minutes. The sales rep indicated that just one screw broke and the other screw also bent for the second cortex. The surgeon does not anticipates any lasting consequences. The rep reported that the surgeon used a right plate on a left wrist.
 
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device remains implanted.
 
Event Description
A distal radius variax plate was fixed to a patient. The most proximal screw went skew through the plate and was then snapped against the furthest cortex. The head of the screw could be removed, the other part is still in the patient's bone. There was a surgical delay of 15 minutes. The sales rep indicated that just one screw broke and the other screw also bent for the second cortex. The surgeon does not anticipates any lasting consequences. The rep reported that the surgeon used a right plate on a left wrist.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLOCKING SCREW, T7 DIAM.2.3X18MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6926729
MDR Text Key252227376
Report Number0008010177-2017-00255
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K080667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-23618E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/07/2017 Patient Sequence Number: 1
-
-