MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW, 10.5 MM, 100 MM, INCLUDING SET SCREW

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device 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 on (b)(6) 2017 upon opening the packaging of the znn cmn lag screw, 10.5 mm, 100 mm, including set screw, the set screw which is usually supplied in the same packaging was missing.The surgery was successfully completed with another device with no delay.Notes: the implantation and explantation dates are left empty as the component involved in this complaint was missing (packaging issue).Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: it was reported that upon opening the packaging of the znn lag screw, the set screw which is usually supplied in the same packaging was missing.Review of received data no other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet.According to the available information, the packaging was discarded.Review of product documentation: - in the dhr 2883596 it is indicated that the set screw was packed with the lag screw.No deviation in the dhr could be found.- a stock investigation was conducted.1 part was opened and checked in the warehouse in france.No deviation could be found.Conclusion summary: it was reported that upon opening the packaging of the znn lag screw, the set screw which is usually supplied in the same packaging was missing.No device has been returned as it was scrapped at the hospital.The device manufacturing quality records (dhr) indicate that the released components met all requirements to perform as intended.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.Additionally, a stock investigation was conducted.1 part was opened and checked in the warehouse in france.The set screw was in the packaging.No deviation was found.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).

• Brand Name: ZNN CMN LAG SCREW, 10.5 MM, 100 MM, INCLUDING SET SCREW
• Type of Device: ZNN CMN LAG SCREW
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7171349
• MDR Text Key: 96994799
• Report Number: 0009613350-2018-00019
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-100-10
• Device Lot Number: 2883596
• Other Device ID Number: 00889024298453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1