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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW REAMER, SHORT ZNN CEPHALOMEDULLARY SMALL GUIDE AND SHORT INSTRUMENTS

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ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW REAMER, SHORT ZNN CEPHALOMEDULLARY SMALL GUIDE AND SHORT INSTRUMENTS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Activation, Positioning or SeparationProblem (2906); Device Damaged by Another Device (2915)
Patient Problem Insufficient Information (4580)
Event Date 08/30/2021
Event Type  Injury  
Manufacturer Narrative
The implantation and explantation dates are left empty as the device involved in this complaint is an instrument. For the same reason, expiration date is also not captured. This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. The manufacturer did not receive surgical reports, x-rays for review. Other documents were received and will be reviewed as part of ongoing investigation. Lot numbers were received and the device history records were reviewed and found to be conforming. The process of gaining necessary information is still ongoing. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
Intraoperative complication involving the fracture of the instrument. No broken pieces were left in the patient and there was no surgical delay.
 
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Brand NameZNN, CMN LAG SCREW REAMER, SHORT
Type of DeviceZNN CEPHALOMEDULLARY SMALL GUIDE AND SHORT INSTRUMENTS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12539509
MDR Text Key273559336
Report Number0009613350-2021-00502
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00-2490-003-64
Device Lot Number4502384728
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
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