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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130A, LEFT, 10 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
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ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130A, LEFT, 10 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.(b)(4).
 
Event Description
During surgery the surgeon faced difficulties while implanting.It was noted that cephalic miller did not get through the nail despite the favorable control before implantation.The nail was removed and replaced by another one.The surgery was extended by about 15 minutes.
 
Event Description
During surgery the surgeon faced difficulties while implanting.It was noted that cephalic miller did not get through the nail despite the favorable control before implantation.The nail was removed and replaced by another one.The surgery was extended by about 15 minutes.
 
Manufacturer Narrative
Additional information was received on (b)(6) 2020.Additionals: a1, a3.Corrections: b4, g4, g7, h10.The manufacturer received other source documents (surgical reports) for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Investigation result is available now.
 
Manufacturer Narrative
Investigation results were made available.Event description: it was reported that cephalic miller did not get through the nail despite the favorable control before implantation.The nail was removed and replaced by another one.The surgery was extended for about 15 min due to the event.Review of received data: surgical report: the surgical report has been reviewed, however no conspicuous findings relevant to the reported event have been identified.Product evaluation: visual examination: the visual examination shows individual very light scratches on the surface of the nail which most likely occurred during handling.At the proximal surface of the lag screw (cephalic) bore hole an area with coarse scratches are is visible.They are located in the proximal half of the bore hole surface while the distal half of the surface appears unscratched.Functional test: a functional test could not be performed as neither the lag screw reamer which was used during implantation, other instruments (e.G.Targeting guide) nor information about these instruments were provided.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Surgical technique: the surgical technique describes how to place the lag screw and respective notes to avoid malalignment including caution notes.One caution note is given on page 14: caution: retighten the connecting bolt to the nail to maintain targeting accuracy.Another note advises: do not impact on the cannula, as the tip of the cannula may skive along the bone and prevent accurate targeting.Further, on page 15 the description emphasizes to choose the correct hole in the targeting guide for the chosen ccd angle.Conclusion: it was reported that cephalic miller did not get through the nail despite the favorable control before implantation.The nail was removed and replaced by another one.The surgery was extended for about 15 min due to the event.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the investigation the reported event can be confirmed.The nail was returned for investigation and showed coarse scratches in the proximal half of the lag screw bore hole¿s surface.It is assumed that the lag screw reamer was not fully aligned with the bore hole and touched the proximal surface of the lag screw hole while reaming.As the lag screw reamer was not returned for investigation a functional test with the reamer and a dimensional test of the reamer could not be performed.However, the device manufacturing history records of the nail indicate that the product was accepted into final stock with no reported discrepancies.Further, the surgical technique describes how to place the lag screw and contains respective notes to avoid malalignment.One potential reason for malalignment is an untightened connecting bolt between the targeting guide and the nail.Nevertheless, based on the investigation this cannot be evaluated.Therefore, based on the available information the reasons for a potential malalignment remain unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
 
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Brand Name
CMN FEMORAL NAIL, CCD 130A, LEFT, 10 MM, 21.5 CM
Type of Device
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
MDR Report Key10239111
MDR Text Key199711722
Report Number0009613350-2020-00307
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024298958
UDI-Public00889024298958
Combination Product (y/n)N
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number47-2493-213-10
Device Lot Number3020389
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/25/2020
Initial Date FDA Received07/07/2020
Supplement Dates Manufacturer Received08/18/2020
12/10/2020
Supplement Dates FDA Received08/27/2020
12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age92 YR
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