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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DYNAMIC MESH STD FOR 2.0MM SCREWS, 200X200MM; IMPLANT
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STRYKER LEIBINGER FREIBURG DYNAMIC MESH STD FOR 2.0MM SCREWS, 200X200MM; IMPLANT Back to Search Results
Model Number 54-00653
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Event Description
It was reported by a company representative that during an in-coming inspection at distribution the presence of foreign material (hair) was found in the blister package.No medical intervention and no adverse consequences were reported as there was no associated procedure.
 
Manufacturer Narrative
Related to the reported event, although the product is available it is not obligatorily necessary to return the product including the package to stryker freiburg for investigation because the report of a hair in the package could be clearly confirmed by means of the provided images.The whole package consists of the outer secondary package (directly printed plastic pouch) and the inner primary package (blister with mesh and foam inside) and ifu.Within the visual inspection it was determined that inside the outer secondary package ¿ directly printed plastic pouch - a hair is visible.Furthermore, it could be determined visually that the package was not opened and is in its original delivery condition.Based on the investigation, the root cause of the reported event - hair in the primary package (plastic pouch) - was attributed to a manufacturing related issue ¿ packaging relevant case.According to this, nc #(b)(4) was initiated on 2019-jun-14.Therefore, no further corrective and/or preventive action is considered to be required at this time.
 
Event Description
It was reported by a company representative that during an in-coming inspection at distribution the presence of foreign material (hair) was found in the blister package.No medical intervention and no adverse consequences were reported as there was no associated procedure.
 
Event Description
It was reported by a company representative that during an in-coming inspection at distribution the presence of foreign material (hair) was found in the blister package.No medical intervention and no adverse consequences were reported as there was no associated procedure.
 
Manufacturer Narrative
At the time of the initial emdr filing of this complaint it was believed that the product involved is sterile.Upon further review it has been verified that the product, 54-00653, is a non-sterile device.Based on this new and updated/corrected information, the complaint now includes the following non-reportable rationale: ¿there were no adverse consequences to the patient, as there was no patient involvement.We have reviewed the historical reportability of this device.There is no history of adverse consequences for the patient in previous similar events, and no information to indicate that adverse consequences would occur if the event were to happen again.Foreign material/hair within the non-sterile packaging would not hinder a surgery nor cause any adverse consequences for the patient as the material would be removed upon sterilization and eliminate the risk of that material being brought into the operating room.Based on a review of the risk documentation and the reported information regarding this event, a report is not required to be filed.¿.
 
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Brand Name
DYNAMIC MESH STD FOR 2.0MM SCREWS, 200X200MM
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE  D-79111
MDR Report Key8686624
MDR Text Key147877691
Report Number0008010177-2019-00034
Device Sequence Number1
Product Code JEY
UDI-Device Identifier04546540237682
UDI-Public04546540237682
Combination Product (y/n)N
PMA/PMN Number
K983528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number54-00653
Device Catalogue Number54-00653
Device Lot Number1000330734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2019
Date Manufacturer Received05/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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