MAUDE Adverse Event Report: ZIMMER GMBH AVENIR RASP

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the devices for investigation or other source documents for review.Three x-rays were received.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.A product failure cannot be confirmed.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be filed.The need for corrective measures is not indicated at this time.(b)(4).

Event Description

It was reported that the surgeon used the avenir rasp hip inst and had trouble with the distal tip of the current broaches.It is stated that the teeth above the polish are cut into the broach, so the polished tip is actually bigger than the broach teeth.This makes it very difficult to get a stem of appropriate size proximal and tends to lead to potting of the stem distally.It was reported that the patient had a distal bone fracture.The surgeon has had three distal fractures.First distal tip fracture is reported in (b)(4) (mfr number 0009613350-2016-01115).Second fracture is reported in (b)(4) (mfr number 0009613350-2016-01118).No further information available at this point of time.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

A technical investigation was not possible to perform, as the devices were not at hand.However, based on the available information the investigation is conducted with outcome as follows.It was reported that the patient had distal bone fracture during the implantation surgery while using avenir rasp.Surgeon had troubles with the distal tip of the current broaches.He is okay with it being blunt or polished, but the teeth above the polished area cut into the broach, so the polished tip is actually bigger than the broach teeth.This makes it very difficult to get a stem of appropriate size proximal and tends to lead to potting of the stem distally.The dhr check could not be performed as the lot number was not available.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Additional information was requested but until today no answer has been received.Conclusion summary: reference and lot numbers of the devices are not available.The devices were not returned for the investigation.Surgical reports and x-rays were not available.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: AVENIR RASP
• Type of Device: AVENIR RASP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6010163
• MDR Text Key: 56787943
• Report Number: 0009613350-2016-01251
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other