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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZNN CMN LAG SCREW 10.5X130 ROD, FIXATION

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ZIMMER, INC. ZNN CMN LAG SCREW 10.5X130 ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2016
Event Type  malfunction  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.
 
Event Description
During a trauma nailing procedure, while looking at the packaging, it was discovered that the lag screw was expired. A second lag screw was obtained, but the packaging showed this was also expired. The surgeon elected to use the second lag screw to complete the procedure.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.  .
 
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Brand NameZNN CMN LAG SCREW 10.5X130
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6140223
MDR Text Key61497929
Report Number0001822565-2016-04510
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2015
Device Model NumberN/A
Device Catalogue Number47-2485-130-10
Device Lot Number2547126
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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