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

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL THREADED PIN 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, INC. ZIMMER NATURAL NAIL THREADED PIN TRAUMA INSTRUMENT Back to Search Results
Catalog Number 00249004732
Device Problem Failure to Advance (2524)
Patient Problem No Patient Involvement (2645)
Event Date 01/12/2017
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. This report is number 2 of 3 mdrs filed for the same event (reference 1822565-2017-00520 / 00522).
 
Event Description
It is reported that during testing of the lag screw reamer and pins, the pins became stuck within the reamer. These were tested outside of any procedure, and had no patient impact.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch. The lag screw reamer and two pins were received for evaluation. The dimensions taken were within specification. It was found that the pin is fractured which remains inside the cannulation of the returned reamer. Also both the returned pins are bent into "u" shapes and exhibit scratches. The device history records were reviewed and no deviations or anomalies were identified. This device is used for treatment. The complaint history reviews were conducted for the devices and found no additional complaints for the same lots. Page 15 of the surgical technique (97-2493-002-00 rev 8 natural nail cephalomedullary standard surgtech-vfinal) states ¿caution: both 3. 0 mm and 3. 2 mm instruments (guide pins, depth gauges, reamers, taps, pin sleeves) are available. The 3. 2 mm versions of the instruments can easily be distinguished as they have gold coating on them. The 3. 0 mm and 3. 2 mm instruments cannot be used interchangeably. Mixing of these instruments can lead to lag screw mis-measurement which could result in patient injury and/or damage to the instruments. ¿ a likely root cause is that a 3. 2mm pin was used with a reamer designed for a 3. 0mm pin. Multiple mdr reports were filed for this event, please see associated reports: 00522-1 and 00520-1.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIMMER NATURAL NAIL THREADED PIN
Type of DeviceTRAUMA INSTRUMENT
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6306881
MDR Text Key66679467
Report Number0001822565-2017-00521
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Assistant
Type of Report Initial,Followup
Report Date 03/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249004732
Device Lot Number63435235
Other Device ID Number(01)00889024063952(10)63435235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-