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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PEG SCREW 2.5MM X 38MM PLATE, FIXATION

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ZIMMER BIOMET, INC. PEG SCREW 2.5MM X 38MM PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Unique identifier (udi) #: n/a. (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 was reported upon incoming inspection at the distributorship, that debris was found in the sterile package. 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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual evaluation of the returned product identified that there is debris inside the sterile package. Ftir analysis conducted on the foreign material in the package identified that it is consistent with the ftir spectra of polyethylene. Device history record was reviewed and no discrepancies were found. The root cause of the reported issue is attributed to manufacturing deficiency. A corrective action has been initiated to address the manufacturing deficiency 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.
 
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Brand NamePEG SCREW 2.5MM X 38MM
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7804794
MDR Text Key117859130
Report Number0001825034-2018-04818
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
PK101240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/05/2019
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 Number131212538
Device Lot Number051400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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