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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER BONE SCREW HWC

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ZIMMER MANUFACTURING B.V. ZIMMER BONE SCREW HWC Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2016
Event Type  Malfunction  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported a hair was in the sealed packaging of the device.

 
Manufacturer Narrative

This report will be amended when our investigation is complete. Received, but not yet evaluated.

 
Manufacturer Narrative

As returned, a hair is confirmed to be present in the tyvek seal. No discrepancy was found during the dhr, and material information sheet (mis) evaluation regarding the operational process. Mis demonstrates that visual inspections were performed and documented accordingly to the applicable curriculum. No scraps were found during the manufacturing process of lot #62153285. This device is used for treatment. Based on the investigation results, the cause was attributed to the operator not following the procedures. The current packaging personnel were assessed on the procedures, and no discrepancy was found between operator execution and the procedures. Inspections instructions were improved and strengthened to avoid and capture nonconformities related to contaminated product (hair in the sterile package). Awareness was provided to disseminate the reported condition. No additional complaint was found related to same failure mode and product family of the reported device, therefore no further actions will be required. The root cause of the hair in the sterile package is that an operator did not follow the procedures.

 
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Brand NameZIMMER BONE SCREW
Type of DeviceHWC
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5646356
MDR Text Key45121992
Report Number0002648920-2016-00836
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00115001200
Device LOT Number62153285
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/24/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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