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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L28MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L28MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 371528S
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2016
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
The customer, reported that when the surgeon,tried to put 4mm locking screws into the distal hole in the plate the head wouldn't go through the hole. A very small part of the head came off one of the screws. It was not reported whether this fell into the surgical site but the customer has the small fragment set aside. The surgeon removed the 4mm screws and replaced them with 3. 5mm locking screws which did go through the axsos distal lateral tibial plate. The sales representative reported that the surgeon did not reverse the 4mm screws first to centralize them ie he omitted the back turn recommended in the ifu. There was a 10 minute delay to surgery the sales representative reported on behalf of the customer that unsuccessful attempts were made to insert three 4mm screws.
 
Manufacturer Narrative
The reported incident that one locking screw axsos 4. 0mm / l75mm was alleged of issue s-11 (breakage during surgery) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. Moreover, since the patient record labels of 8 axsos 4. 0mm locking screws were provided but it was not specified which of the screws is the one which broke, all the 8 screws have been investigated for sake of safety and completeness. Based on investigation, the root cause was attributed to a user related issue. The failure was caused by incorrect surgical procedure. Indeed, as reported by the sales representative, the surgeon did not reverse the axsos 4. 0mm locking screws a few turns in order to adjust screw alignment when necessary, thus leading to screw head breakage. Please note that the operative technique (axsos-st-3 en rev 2 axsos proximal lateral tibia optech) states the following: ''if power insertion is selected after manual start (see above), use low speed only, do not apply axial pressure, and never ¿push¿ the screw through the plate! allow the single, continuous threaded screw design to engage the plate and cut the thread in the bone on its own, as designed. Stop power insertion approximately 1cm before engaging the screw head in the plate. Power can negatively affect screw insertion, if used improperly, damaging the screw/plate interface (screw jamming). This can lead to screw heads breaking or being stripped. Again, if the locking screw does not advance, reverse the screw a few turns, and realign it before you start reinsertion. '' furthermore, the instruction for use (v15013 rev m non active implant ifu ot-ifu-105 rev 2) was reviewed and the following applicable warnings were identified: ''ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system. For your information, avail yourself of the training courses and publications offered. Intra-operative: avoid surface damage of implants. '' 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.
 
Event Description
The customer, reported that when the surgeon,tried to put 4mm locking screws into the distal hole in the plate the head wouldn't go through the hole. A very small part of the head came off one of the screws. It was not reported whether this fell into the surgical site but the customer has the small fragment set aside. The surgeon removed the 4mm screws and replaced them with 3. 5mm locking screws which did go through the axsos distal lateral tibial plate. The sales representative reported that the surgeon did not reverse the 4mm screws first to centralize them ie he omitted the back turn recommended in the ifu. There was a 10 minute delay to surgery. The sales representative reported on behalf of the customer that unsuccessful attempts were made to insert three 4mm screws.
 
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Brand NameLOCKING SCREW AXSOS 4.0MM / L28MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5450803
MDR Text Key38727203
Report Number0008031020-2016-00069
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K050512
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 01/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number371528S
Device Lot NumberJ15720
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2015
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: 02/22/2016 Patient Sequence Number: 1
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