MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, RIGHT, 13 MM, 42 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item# 47-2493-420-13, lot# 2792655r, cmn femoral nail, ccd 125 right,13 mm, 42cm.Device evaluated by manufacturer: the manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 the patient had a revision approximately 2 months post implantation due to implant fracture.Attempts to obtain additional information has been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Correction: b4, d5, e4, g4, g7, h10.Additional: d10, h2, h6.Event summary: product was implanted on (b)(6) 2018 and revised on (b)(6) 2019 due to implant fracture.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis; visual examination: the broken znn nail, lag screw and set screw were returned for investigation.The nail was broken into two parts.The fracture of the nail is located through the lag screw hole.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.At the edge of the lag screw hole of the znn nail some damages and deformations can be seen.It can be assumed that the lag screw hole was damaged during the implantation (for example by a reamer while reaming for the lag screw placement).The fracture surfaces shows also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Several scratches are visible on the surface of the nail.The lag screw shows circular marks on the shaft area.No damages or deformations visible on the set screw.Based on this visual examination the reported event can be confirmed.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from (b)(4) and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed and are according to specification.Conclusion summary: it was reported that the patient had a revision surgery due to a znn nail fracture.The nail was in vivo for approximately 3 months.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.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).The visual examination of the nail indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Fatigue fractures occur due to a cyclic overloading.Possible contributing factors to the overload could be wrong patient behaviour, a not properly healed bone fracture and / or possible damage of the lag screw hole during implantation.However, based on the available information and performed investigation, an exact root cause for the plate 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).
Event or Problem Description
No change to previously reported event.

• Brand Name: CMN FEMORAL NAIL, CCD 125, RIGHT, 13 MM, 42 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: 8629340
• Report Number: 0009613350-2019-00319
• Device Sequence Number: 14017284
• Product Code: HSB
• UDI-Device Identifier: 00889024300170
• UDI-Public: 00889024300170
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-420-13
• Device Lot Number: 2792655R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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 Age: 73 YR