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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Unsealed Device Packaging (1444); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 06/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (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. Multiple mdr reports were filed for this event, please see all associated reports: 0001822565-2018-03933, 0001822565-2018-03940, 0001822565-2018-03941, 0001822565-2018-03942, 0001822565-2018-03943, 0001822565-2018-03944, 0001822565-2018-03945, 0001822565-2018-03946, 0001822565-2018-03947.
 
Event Description
It was reported during the incoming inspection of the product at the distributorship, a foreign substance was found in the package and a crease was noted in the sealing area. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Evaluation of the eight (8) returned products confirmed the presence of crease and/or fold in the seal of the pouches. Device history record was reviewed and no discrepancies were found. A manufacturing deficiency was considered as the root cause of the reported issue. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported during the incoming inspection of the product at the distributorship, a crease was noted in the sealing area. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameZNN TEAR 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 Key7804774
MDR Text Key117857591
Report Number0001822565-2018-03943
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
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 Number64006741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0542-2019

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