MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 135 RIGHT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: cephalomedullary nail cap 15 mm height; catalog#: 47248700215; lot#: 64537545; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog#: 47248403250; lot#: 64648922.Therapy date: (b)(6) 2020.The manufacturer received x-rays and 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to nail fracture.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g4, g7, h10.Event description: it was reported that the product was implanted in (b)(6) 2020 and revised on (b)(6) 2020 due to nail fracture.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.- x-rays: some intra-operative x-ray pictures were received.The x-rays are undated.On one x-ray the nail seems to be broken.Unfortunately the x-rays are undated and a detailed x-ray documentation is not available.Therefore, no meaningful statement can be made.- images: there are also some pictures of the components available.The breakage of the znn nail through the hole for the lag screw can be confirmed.In addition, the lag screw and two screws can be seen.Product evaluation: no product was returned to zimmer biomet.Therefore, visual and dimensional evaluation of the broken znn nail could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.- 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.- complaint history search: a complaint history search for the znn nail with reference (b)(4) and lot 2880665 was done.No other complaints found with the same reference and lot combination.Conclusion: it was reported that the product was implanted in (b)(6) 2020 and revised on (b)(6) 2020 due to nail fracture.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the znn nail have met the specifications valid at the time of production.The raw material certificate of the nail was reviewed with no anomalies noted.The complaint history search identified no additional complaints for the same reference and lot number combination.The investigation did not identify a nonconformance or a complaint out of box (coob).The received x-ray pictures and the product images confirm the breakage of the znn nail.The breakage is located through the hole for the lag screw.As the nail was not returned for evaluation, a detailed investigation of the fracture surface could not be performed.Based on the available information and performed investigation, an exact root cause for the nail breakage 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)(4).The following reports are associated with this event: 0009613350-2020-00456; 0009613350-2020-00453.

• Brand Name: CMN FEMORAL NAIL, CCD 135 RIGHT, 13 MM, 21.5 CM
• Common Device Name: 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: 10626476
• Report Number: 0009613350-2020-00456
• Device Sequence Number: 3559579
• Product Code: HSB
• UDI-Device Identifier: 00889024299016
• UDI-Public: 00889024299016
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-214-13
• Device Lot Number: 2880665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 01/22/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 86