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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.5 PEEK ALLTHREAD III SCREW, FIXATION, BONE

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ZIMMER BIOMET, INC. 5.5 PEEK ALLTHREAD III SCREW, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problems Out-Of-Box Failure (2311); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2015
Event Type  Malfunction  
Manufacturer Narrative

Zimmer biomet complaint (b)(4). Complaint sample was evaluated and the reported event was confirmed. Product evaluation stated,"product was reviewed and found to conform the packaging validation. The damage was deemed excessive beyond tested samples used in the simulated distribution test. " dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Investigation results concluded that the reported event was due to excessive force during shipping. 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. This report is being submitted late as it has been identified in remediation.

 
Event Description

The anchor packaging was damaged upon opening and therefore sterility was questionable.

 
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Brand Name5.5 PEEK ALLTHREAD III
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6954322
MDR Text Key90530434
Report Number0001825034-2017-08635
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberPK080088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/29/2019
Device MODEL NumberN/A
Device Catalogue Number904921P
Device LOT Number704770
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/26/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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