MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW REAMER, SHORT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during the surgery, the taper tip of the cmn lag screw reamer has fractured and lodged in patient's bone.

Manufacturer Narrative

Event description: event summary: it was reported that the taper tip of the cmn lag screw reamer has fractured and lodged in patient's bone.A new lag screw reamer has been used.There was a delay of 30 minutes during surgery trying to remove the broken piece.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 znn lag screw reamer was returned for investigation.The tip of the reamer has fractured off.The broken piece of the reamer is also returned for examination.The cutting edges are worn and not sharp anymore.The fracture surfaces show polishing and damage which most likely occurred after the fracture.The fracture surfaces were not further investigated and the nature of the fracture could not be determined.In addition, the fracture surface shows some corrosion spots which can be attributed to flash rust that occurred after the fracture.The hardness of the material was tested.With a measured value of 53 hrc it was found to be within the required specifications of 55±3 hrc defined in aau q.20.256 (hardening and tempering for material 1.4112).Review of product documentation: this device is intended for treatment.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 on (b)(6) 2020, and is according to specification.Surgical technique sap doc no.97-2493-005-00 rev.7 11/16: see for correct placement and positioning of the lag screw reamer and guide pin.Product drawing sap doc no.063.325.425 rev.A: see for hardening requirements.Conclusion summary: it was reported that the lag znn screw reamer was fractured during the reaming and lodged in patient's bone.The fracture could be confirmed by visual examination.The fractured piece of the reamer was also available for investigation.No pieces left in patient¿s body.The znn lag screw reamer was returned for investigation and confirms the reported event.The quality records show that all specified characteristics (material, dimensions, surface, etc.) 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).Additionally, the hardness test showed that the material is still within the required specifications.The cutting edges are worn and not sharp enough anymore to fulfill the function of the device.The device was manufactured in 2011.Therefore, the device was on the market for more than 9 years.It can be assumed that the device was used in different surgeries for several times.Macroscopically, no defects can be observed on the fracture surfaces that could trigger or contribute to the fracture.It is possible that the not sharp enough cutting edges might have led to an increased force leading to the fracture.Another possible root cause might be, that the guide pin, which will be inserted into the cannula of the lag screw reamer, was slightly bent or has migrated.Consequently, the reamer could have come into contact with the pin, leading to the breakage of the tip.It might be also possible, that the lag screw reamer was in contact with the znn nail during the reaming procedure, which might have led in combination with high applied forces to the fracture of the instrument.Moreover, the bone quality of the patient could have also influenced the event.Based on the available information and performed investigation, the reasons for the fracture might be multifactorial and we were not able to identify an exact root cause for the fracture of the znn lag screw reamer.

Event Description

Investigation result is available now.

• Brand Name: ZNN CMN LAG SCREW REAMER, SHORT
• Type of Device: ZNN CMN LAG SCREW REAMER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8762168
• MDR Text Key: 150108321
• Report Number: 0009613350-2019-00426
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024276260
• UDI-Public: 00889024276260
• 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
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-2490-003-64
• Device Lot Number: 11.644338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 27 YR