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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT SCREW

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STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT SCREW Back to Search Results
Catalog Number UNK_FRO
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/16/2015
Event Type  malfunction  
Event Description
The sales rep reported on behalf of the customer that while placing a variax distal radius plate 3 screws broke.The heads of the screws broke off.The surgeon reported not to have used excessive force while placing the screws.The surgeon continued the procedure with the same plate.The ends of the screws are still present in the plate.The surgeon attached the plate by placing additional screws very carefully.The surgeon choose to use a 2.0 burr to attach the 3.0 screws.
 
Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.Unk bone screw.
 
Manufacturer Narrative
The reported incident that unknown_fro_product was alleged of issue s-11 (breakage during surgery) could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by too much high torsional force during insertion.The device inspection revealed the following: as indicated on the event description; ¿the customer continued the procedure with the same plate.The surgeon attached the plate buy screwing in additional screws very carefully.As an action and in order to be careful not to break the final screws, the surgeon choose to use a 2.0 burr to attach the 3.0 screws.¿ this gives us a clear indication that the surgeon did not predrilled prior to screw insertion (also possible hard bone material could have cause some problem, unfortunately no information regarding bone strengths has been given).Please see ifu below for further details, in order to prevent such problems in the future.The instruction for use (90-03200 rev g 03-2014 implants dr, non locking ifu_low res vax_ifu-2); screw precautions and warnings: placement of all locking screws requires the use of a drill guide to ensure proper screw placement.If a drill guide is not used the screw may not lock into the plate.Locking screws may not lock properly into the plates long elliptical hole.Therefore we recommend using regular bone screws.When engaging the screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head.This results in proper axial alignment and full contact between driver and screw, minimizing the risk of damage and leading to optimal friction fit performance.Screws should not be over tightened during insertion.Excessive over tightening will compromise the integrity of the screw head, result in possible screw and screwdriver blade breakage or deformation, and lead to loss of friction fit performance.Excessive tightening of the locking screw may lead to titanium particle generation.Particles should be removed to prevent potential inflammation.Excessive tightening of the locking screw may lead to stripping of the locking threads.In the event that a locking screw thread strips out, a bone screw should be used.A review of the device history was not possible because the article number nor the lot number was communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
 
Event Description
The sales rep reported on behalf of the customer that while placing a variax distal radius plate (b)(4) screws broke.The heads of the screws broke off.The surgeon reported not to have used excessive force while placing the screws.The surgeon continued the procedure with the same plate.The ends of the screws are still present in the plate.The surgeon attached the plate by placing additional screws very carefully.The surgeon choose to use a 2.0 burr to attach the 3.0 screws.
 
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Brand Name
UNKNOWN_FRO_PRODUCT
Type of Device
IMPLANT SCREW
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4685123
MDR Text Key5642432
Report Number0008010177-2015-00070
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/19/2015
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
Device Operator Health Professional
Device Catalogue NumberUNK_FRO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/19/2015
Initial Date FDA Received04/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/08/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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