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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION

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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Dent in Material (2526)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Udi - (b)(4). Report source- (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It is reported that upon incoming product inspection the product was found with a crease in the sealing area which could potentially compromise sterility. No adverse events were a result of this malfunction as there was no patient involvement.
 
Manufacturer Narrative
Review of the packaging determined that no failure was found as the products are within specification(s). No further investigation or action is required after review. The initial report was forwarded in error and should be voided.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8032402
MDR Text Key126083561
Report Number0001822565-2018-06060
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009700
Device Lot Number64040387
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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