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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADLESS COMPRESSION SCREW SCREW, FIXATION, BONE

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ZIMMER BIOMET, INC. HEADLESS COMPRESSION SCREW SCREW, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problems Component Missing (2306); Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source: (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. 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 that the product was received in an unsealed bag with a screw missing. No adverse events have been reported as a result of the malfunction.

 
Manufacturer Narrative

Review of the provided photograph determined that the packaging is open, unsealed, and no product can be seen. As the product was not returned, further evaluation could not be performed. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no trends were identified. The root cause of the reported issue is attributed to a manufacturing deficiency. 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 NameHEADLESS COMPRESSION SCREW
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 Key6963847
MDR Text Key89858541
Report Number0001825034-2017-09114
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberPK142658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number110018421
Device LOT Number496610
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2016
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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