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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW ROUND HEAD 7X20MM; SCREW, FIXATION
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ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW ROUND HEAD 7X20MM; SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional concomitant medical products: the commingled product that was inside of the package was: part#: 905629 lot#: 625450; manufacture date: october 19, 2017; sterile expiry date: october 19, 2022.(b)(4).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 submitted for this event, please reference the following report numbers: 0001825034-2018 -04489, 0001825034 -2018-04520, 0001825034 -2018-04521, 0001825034-2018-04522, 0001825034-2018-04524, 0001825034 -2018 -04525, 0001825034-2018-04526, 0001825034-2018-04534, 0001825034-2018- 04536, 0001825034-2018-04537.Not yet returned.
 
Event Description
It was reported that during an acl reconstruction procedure, it was discovered that the product inside was not the correct product and did not match the product id on the outer label.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
(b)(4).Reported event was confirmed by review of the pictures of the products sent.The box and inner packaging do not have the same item & lot numbers on the labels.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to manufacturing deficiency related to production & process control.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
No further event information available at the time of this report.
 
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Brand Name
GENTLE THREADS INTERFERENCE SCREW ROUND HEAD 7X20MM
Type of Device
SCREW, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7778299
MDR Text Key116944424
Report Number0001825034-2018-04520
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
PK982497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/10/2022
Device Model NumberN/A
Device Catalogue Number905612
Device Lot Number611330
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-3176-2018, Z-3177-2018
Patient Sequence Number1
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