MAUDE Adverse Event Report: ZIMMER GMBH ANKLE FIX DRILL-GUIDE 3.2 SYS 4RED 65MM; NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices for review.X-rays or other source documents were not provided for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Additional information has been requested and is currently not available.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that during an ankle fusion surgery, while using the compression device, the two drill guides used along with it buckled at the point where they screw into the plate, the threaded section one was snapped.Following this the surgeons then struggled to get the locking screws to sit flush within the plate.

Manufacturer Narrative

D11 concomitant medical products: medical product: drill guide for 3.2 drill, sys4.0, item# 503004047, lot# 028a15.Therapy date: (b)(6) 2018.Device history records (dhr): normed medizin-technik gmbh is a medical device company located in tuttlingen, germany.Normed maintains a quality management system for design, manufacture and final inspection of the respective devices /device categories in accordance with mdd annex ii and which fulfills the requirements of iso (b)(4).During the final inspection of products at normed, the inspection of each batch was performed according to established inspection plans.Only if all inspection characteristics passed the final inspection, the release to market was granted and the products were transferred from the quarantine area to the warehouse.If a non-conformity was detected the affected parts were either reworked, scrapped or ¿ if possible ¿ a concession was granted.Therefore it can be concluded that the released components met all requirements to perform as intended.A trend considering the following event is identified: breakage / bending of the drill guide (thread) event summary: it was reported that during application with the compression device, two drill guides buckled at the point where they screw into the plate.One more drill guide fractured at the threaded section.Following this the surgeons struggled to get the locking screws to sit flush within the plate.Review of received data: no medical data such as xrays, surgical notes or any other caserelevant documents received.Devices analysis: visual examination: three drill guides have been received for an investigation.Two of them show no defect, the threads seem to be fully functional.The threads of the third one have fractured off and have not been returned.Measurement: the inner diameters of the instruments have been measured.The dimension is defined as ø3.3 mm 0/+0.1.A measuring pin with a diameter of 3.38 mm (within specification) could still be inserted into the bore hole.Moreover, the diameters have been measured using a digital measuring slide of control number z7568.The dimensions were found to be with ø3.83.4mm within specification as defined on the product drawing.Moreover, as the instruments have already been used in a surgery, the dimension could have altered.Review of product documentation: ankle fix surgical technique contains information and illustrations about all the steps needed for the implantation of the plate.Root cause analysis: root cause determination using rmw: instrument breaks, deforms, diverge or parts remain in wound due to mechanical properties of material insufficient not possible >a systematic issue with material properties would have been detected as part of the issue evaluation assessment.Deterioration in function due to wrong, inadequate maintenance possible, as it is unknown whether the instrument was maintained adequately.Dysfunctionality / malfunction of defective devices and instruments due to mishandling of device by user possible, as it is unknown whether the user did fully insert the thread of the drill guide into the screw holes of the plate.High forces might have been transmitted and the threads broke off.Malfunction, insufficient device performance or durability due to 1) user´s disregard of manufacturer´s recommendation 2) use error (slips,lapses, mistakes, reasonably foreseeable misuse) 3) abnormal use beyond risk possible, as it is unknown whether the user did fully insert the thread of the drill guide into the screw holes of the plate.Functionality and applicability of the c/d device is hindered due to difficulty in applying the device with the drill guides on threaded screw holes possible, as it is unknown whether the drill guide was tightened correctly in the thread of the screw hole.This might have contributed to the instrument breakage.Conclusion summary: it was reported that two drill guides buckled at the point where they are screwed into the plate.One more drill guide fractured at the threaded section.It can be confirmed that the threads of one drill guide have fractured off.The other two drill guides show no defect.According to the surgical technique, the two drill guides act as connection between the plate and the compression device.The compression is applied on the fixation pin and plate (via drill guides).The drill guides should transmit the compression from the pin to the plate.There is no direct compression between the two drill guides.According to the reported event, the possible reason for the breakage is suspected to be improper fixation of drill guide into the plate.If the thread of the drill guide is not fully threaded into the screw holes of the plate, too high forces will be transmitted on the thread which leads to a fracture of the thread.Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions.Should the results of the further investigation indicate the necessity of a remedial action/corrective action/preventive action/field safety corrective action, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: ANKLE FIX DRILL-GUIDE 3.2 SYS 4RED 65MM
• Type of Device: NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7608845
• MDR Text Key: 111443452
• Report Number: 0009613350-2018-00625
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK123347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: 503004047
• Device Lot Number: 028A15
• Other Device ID Number: 00889024111547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1