• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW REAMER, SHORT TRAUMA INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW REAMER, SHORT TRAUMA INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Medical product: z nail 10. 5 x 110 lag screw; catalog#: 47-2485-110-10; lot#: 3061196. Z nail 5. 0x35 cort screw fa; catalog#: 47-2484-035-50; lot#: 65133376. Znn, cmn threaded pin, 3. 2 mm; catalog#: 00-2490-450-32; lot#: unknown. Znn, cmn drill, calibrated, 4. 3 mm; catalog#: 00-2490-066-43; lot#: unknown. Cmn femoral nail, ccd 130, left, 11. 5 mm, 21. 5 cm; catalog#: 47-2493-213-11; lot#: unknown. The manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. 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
It was reported that during surgery the tip of the lag screw reamer fractured inside the patient. It was safely retrieved and confirmed with x-ray. Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument. Hence, no expiration date is captured, for the same reason.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZNN, CMN LAG SCREW REAMER, SHORT
Type of DeviceTRAUMA INSTRUMENT
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 Key12589553
MDR Text Key276577048
Report Number0009613350-2021-00518
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00-2490-003-64
Device Lot Number16277660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/07/2021 Patient Sequence Number: 1
-
-