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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK GLENOSPHERE FORCEPS
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ZIMMER BIOMET, INC. UNK GLENOSPHERE FORCEPS Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.
 
Event Description
It was reported that the edge of the insertion forceps broke off the tip of the instrument approx.5mm.No injury to the patient.The patient was x-rayed intra-operatively and no forceps fragment could be seen on multi-view x-rays.Attempts have been made and no further information have been provided.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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 additional event information is available at the time of this report.
 
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Brand Name
UNK GLENOSPHERE FORCEPS
Type of Device
FORCEPS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8807384
MDR Text Key151710642
Report Number0001822565-2019-03109
Device Sequence Number1
Product Code HTD
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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