MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125°, LEFT, ø 10 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer did not receive x-rays, or other source documents for review.Device history record (dhr) was reviewed and no discrepancies were found.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 or Problem Description
It was reported that during surgery it was not possible to insert lag screw through nail.A new nail was opened and implanted.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
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 or Problem Description
Please refer to report 0009613350-2019-00041.
Additional Manufacturer Narrative
Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.A concession was found that has no effect on the effectiveness of the product.Review of event description: it was reported that during the surgery on (b)(6) 2019, cmn femoral nail was inserted and removed for failure to drill and insert lag screw through nail.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: visual examination: the znn nail was returned for investigation.No other components have been received.The visual examination shows that the hole for the lag screw is damaged.It can also be seen than the lag screw hole shows signs of drilling.It can be assumed that this happened during the surgery.No other damages or deformations can be seen.Measurements: as the lag screw hole is deformed a measurement cannot be done.Functional test: as the lag screw hole is deformed a functional test cannot be done.Review of surgical technique: the correct lag screw placement is described on pages 13 - 19.The following should also be considered: the lag screw hole labeled 125 is designed to be used with the long and short nails containing a 125° ccd angle, the lag screw hole labeled 130 is designed to be used with the long and short nails containing a 130° ccd angle, and the lag screw hole labeled 135 is designed to be used with the short nails containing a 135° ccd angle.Conclusion summary: it was reported that during the surgery on (b)(6) 2019, znn femoral nail was inserted and removed for failure to drill and insert lag screw through nail.The removed znn nail was returned zo zimmer biomet for investigation and the surgery was finished with using another znn nail.No lag screw has been returned.The quality records show that all specified characteristics have met the specifications valid at the time of production.The visual examination of the device sows that the lag screw hole is damaged and deformed.There are also signs of drilling.It can be assumed that the nail was drilled during the surgery.Therefore, the lag screw hole is deformed.The correct lag screw placement into the nail is described in the surgical technique 97-2493-005-00.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information and performed investigation, an exact root cause could not be determined.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)(6).
Event or Problem Description
Please refer to report 0009613350-2019-00041.

• Brand Name: CMN FEMORAL NAIL, CCD 125°, LEFT, ø 10 MM, 21.5 CM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8309461
• Report Number: 0009613350-2019-00041
• Device Sequence Number: 1682970
• Product Code: HSB
• UDI-Device Identifier: 00889024298873
• UDI-Public: 00889024298873
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-211-10
• Device Lot Number: 2771097
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/05/2019; 09/11/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 02/18/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 24 YR