MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW¸ 10.5 MM, 100 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical products and therapy date.Detail of product: item number 47249321110, item name cmn femoral nail, ccd 125, left, 10 mm, 21.5 cm, lot #:2978853.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that during surgery although the lag screw was inserted inside the nail, it couldn't inserted till the proper position.
Event or Problem Description
Please refer to report 0009613350-2019-00543.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: assembly issue.Event description: it was reported that during implantation of a cm nail system on (b)(6) 2019, the lag screw could not be correctly inserted into the already implanted nail.Surgery was finished with an alternative product.Moreover it is mentioned, that the outer diameter of the lag screw might be out of specifications.Review of received data: no medical data or any other case-relevant documents received.Two pictures have been received.One of them shows, that the lag screw does not fit through the bore hole of a cm nail.Device analysis: visual examination: the lag screw as well as the set screw has been returned for an investigation.The lag screw shows a few fine scratches.No other conspicuousness found.See pictures attached.Measurement: the outer diameter of the lag screw has been measured with the micrometer (caliper mt 2044) and was found to be with 10.53mm out of the specification of ø 10.5 -0.02/-0.05 as defined in the product drawing.Additionally the lag screw was tested with the gauge of id (b)(4) which was also used during manufacturing to test the outer diameter of the lag screw.The gauge could not be fitted on the outer diameter of the lag screw.Review of product documentation: all involved devices are intended for treatment.Dhr review: in the dhr it is indicated on page 38, that the outer diameter all 90 produced parts have been measured using the gauge 10.5.Conclusion: it was reported that during implantation of a cm nail system on (b)(6) 2019, the lag screw could not be correctly inserted into the al nail.The lag screw has been returned and the outer diameter was found to be out of specifications.Therefore the reported event can be confirmed.Based on the available information further investigation ((b)(4)) 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).

• Brand Name: ZNN, CMN LAG SCREW¸ 10.5 MM, 100 MM, INCLUDING SET SCREW
• 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: 8949610
• Report Number: 0009613350-2019-00543
• Device Sequence Number: 14057966
• Product Code: HSB
• UDI-Device Identifier: 00889024298453
• UDI-Public: 00889024298453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-100-10
• Device Lot Number: 2977933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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