MAUDE Adverse Event Report: ZIMMER GMBH ANKLE FIX COMPRESSION/DISTRACTION INSTRUMENT

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer did not receive x-rays, or other source documents for review.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).The following report is associated with this event: 0009613350-2018-00623.

Event Description

It was reported that during an ankle fusion surgery upon opening the set, the pin with screw head was missing in the set.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Dhr-review: 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 fulfils 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.Trend analysis: no trend considering the following event is identified: missing instrument.Event description: it was reported that the pin, which is used with the compression device, was missing in the kit.Devices analysis: visual examination: the compression device of ref (b)(4) was returned for an investigation.A few signs of usage are visible.Otherwise, the compression device seems to be fully functional.Conclusion summary: it was reported that the pin, which is used with the compression device, was missing in the kit.This issue is not address any product issue or malfunction.It addresses a supply chain matter.According to the information received from the warehouse in bridgend, the missing instrument has been detected prior to sending the kit to the hospital.According to applicable process, the sales executive or deputy has been informed.Moreover it was found, that at the current point in time (nov 2018) there is a sufficient stock of this instrument.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.(b)(4).The following reports are associated with this event: 0009613350 - 2018 - 00623 - 1.

Event Description

No new information.

• Brand Name: ANKLE FIX COMPRESSION/DISTRACTION INSTRUMENT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7600310
• MDR Text Key: 111757586
• Report Number: 0009613350-2018-00622
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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: 28.14.000
• Device Lot Number: 389B14
• Other Device ID Number: 0088902410773
• 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: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PIN, ITEM# 28.14.140, LOT# UNKNOWN