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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.5MM / L18MM; PLATE, FIXATION, BONE
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STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.5MM / L18MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number PLSL3518S
Device Problems Component Falling (1105); Metal Shedding Debris (1804)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/21/2017
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The surgeon reported that she was inserting a 3.5mm screw into an anchorage foot plate and that during tightening, a small shaving of metal came off the screw.The shaving fell onto the bone and was immediately retrieved using forceps.The surgeon attempted to implant 2 further screws and these also appeared to be too big for the plate.Surgery was completed using a 3.00mm screw instead.There was a 5 minute delay to surgery.
 
Manufacturer Narrative
The reported event that locking screw anchorage ø3.5mm / l18mm was alleged of 'device damaged' could be confirmed, since the returned device is slightly damaged on the thread of the head.Based on investigation, the root cause was attributed to be user related.Please follow exactly the corresponding op-tech to avoid damaging the screw.When using the drill guide the thread of the screw cannot touch the plate and therefore the screw cannot be damaged by the plate.One possibility is that the surgeon was drilling without a drill guide and therefore the hole for the screw was decentered.When the surgeon was inserting the screw in the decentered hole the screw was damaged by touching the plate.Other possible causes leading to this damage on the thread of the head could be: debris in the threads interfering with screw advancement or over torque applied during screw tightening.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 any further information is provided, the investigation report will be updated.
 
Event Description
The surgeon reported that she was inserting a 3.5mm screw into an anchorage foot plate and that during tightening, a small shaving of metal came off the screw.The shaving fell onto the bone and was immediately retrieved using forceps.The surgeon attempted to implant 2 further screws and these also appeared to be too big for the plate.Surgery was completed using a 3.00mm screw instead.There was a 5 minute delay to surgery.
 
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Brand Name
LOCKING SCREW ANCHORAGE Ø3.5MM / L18MM
Type of Device
PLATE, 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 Key6697368
MDR Text Key79668334
Report Number0008031020-2017-00399
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K083447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue NumberPLSL3518S
Device Lot NumberV39985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2016
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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