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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH HUMERAL PLATE,DISTAL-LATERAL,RIGHT EPI-UNION 8 HOLES, 105MM FOR SCREWS 3.5/4.0M; PLATE, FIXATION, BONE
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STRYKER GMBH HUMERAL PLATE,DISTAL-LATERAL,RIGHT EPI-UNION 8 HOLES, 105MM FOR SCREWS 3.5/4.0M; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 12790108
Device Problem Bent (1059)
Patient Problem No Code Available (3191)
Event Date 10/26/2015
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The risk manager at the hospital, returned the device to stryker (b)(4) and reported the following event, "this plate was implanted on (b)(6) 2015, on a patient who had a humeral fracture.During an x-ray control (the day after the implantation), the plate was bent, all the screws were their initial position." patient was revised.
 
Manufacturer Narrative
The reported event that humeral plate,distal-lateral,right epi-union 8 holes, 105mm for screws 3.5/4.0m was allegedly of issue s-16 (device deformed) could be confirmed, since the returned device matched the reported failure.The device inspection revealed that the plate is bent in one of the middle holes of the plate.The failure might have occurred if the plate was pre-damaged, during storage for example.Since this device was manufactured in 2006, it is unknown in which conditions it was stored and it cannot be excluded that it might have contributed to the event.Careful inspection is recommended to access the condition of the implants.Note, as stated in the ifu: ¿pre-operative: the implant is for single use only.Inspection is recommended prior to surgery to determine if implants have been damaged during storage.¿ moreover, this plate is pre-contoured so it should not be bent during surgery.It is unknown if this was the case, however it cannot be excluded that the plate was bent during surgery.Note, as stated in the epi union brochure: ¿anatomical shaping: pre-contoured for left or right variations; pre-shaped to aid reduction, particularly in complex and comminuted fractures; eliminates manual contouring, simplifying and reducing operative time¿ [original statement(s)].Additionaly, although the occurrence of a trauma is unknown it cannot be excluded that it happened and that it caused the plate to bend.Note, as stated in the ifu: ¿informing the patient: the implantation affects the patient's ability to carry loads and her/his mobility and general living circumstances.For this reason, each patient needs individual instructions on correct behavior after the implementation.The patient should be warned that the device cannot and does not replicate a normal healthy bone, that the device can break or become damage as a result of strenuous activity or trauma, and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.¿ based on investigation, the root cause is likely to be a user related issue.However, 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 any further information is provided, the investigation report will be updated.
 
Event Description
The risk manager at the hospital, returned the device to stryker (b)(4) and reported the following event, "this plate was implanted on (b)(6) 2015, on a patient who had a humeral fracture.During an x-ray control (the day after the implantation), the plate was bent, all the screws were their initial position." patient was revised.
 
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Brand Name
HUMERAL PLATE,DISTAL-LATERAL,RIGHT EPI-UNION 8 HOLES, 105MM FOR SCREWS 3.5/4.0M
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 Key5354634
MDR Text Key35463716
Report Number0008031020-2016-00002
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K974289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 12/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number12790108
Device Lot NumberM09802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received02/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2006
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) Required Intervention;
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