MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2020

Event Type  Injury  

Manufacturer Narrative

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 yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 nail present in the box was a 10mm instead of 11.5mm as mentioned in the label.The box was found to be mislabeled as 11.5mm and hence the surgery was delayed by 45-60 minutes.

Event Description

During surgery the nail present in the box was a 10mm instead of 11.5mm as mentioned in the label.The box was found to be mislabeled as 11.5mm and hence the surgery was delayed by 45-60 minutes.

Manufacturer Narrative

Additional information was received on feb 01, 2021.The manufacturer received x-rays, 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).

Manufacturer Narrative

Event description: it was reported that during surgery the nail present in the box was a 10mm instead of 11.5mm as mentioned in the label.The box was found to be mislabeled as 11.5mm.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the visual examination shows no obvious deviation.The nail is laser marked with item # 47-2493-213-11, lot # 3025629 and the description ø11.5mm x 21.5cm 130° l.Measurements: the returned nail was measured.It showed that the nail, lasermarked as item # 47-2493-213-11 and 130° ccd, has in fact a 125° ccd angle.Therefore the angle of the nail is out of specification.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): review of the ncrs identified no deviations or anomalies during manufacturing.Ie/capa/hhe(d) search: the issue of this complaint will be included in the existing capa ca-06035.Conclusion: it was reported that during surgery the nail present in the box was a 10mm instead of 11.5mm as mentioned in the label.The box was found to be mislabeled as 11.5mm.Based on the investigation the reported event can be confirmed.The investigation did identify a nonconformance or a complaint out of box (coob).The investigation showed that the reported cmn femoral nail, lasermarked as item # 47-2493-213-11 and 130° ccd, has in fact a 125° ccd angle.Therefore the angle of the nail is out of specification.Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: CMN FEMORAL NAIL, CCD 130, LEFT, 11.5 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 Key: 11129833
• MDR Text Key: 225484390
• Report Number: 0009613350-2021-00002
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298965
• UDI-Public: 00889024298965
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-213-11
• Device Lot Number: 3025629
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR