MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERIARTICULAR DISTAL MEDIAL TIBIAL LOCKING PLATE; TRAUMA PROSTHESIS

Catalog Number 00235700710

Device Problem Difficult to Insert (1316)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2016

Event Type  malfunction  

Manufacturer Narrative

No product was returned for review.The device history records for the tibial locking plate, were reviewed and identified no deviations or anomalies.The product was not returned for review; therefore the exact condition of the device is unknown.This device is used for treatment.A product history search was conducted for the device.The search identified no additional complaints for the same lot and identified no complaints with a same or similar issue for the part.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported that when the locking plate was prepared prior to surgery at the distributor's office, that the nut couldn't be inserted into the locking hole entirely and the plate could not be used.This was discovered outside of any procedure and had no patient impact.Another device was available and used for the proceeding surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: complaint sample was evaluated and the reported event was confirmed.As returned, one of the threaded holes exhibits a burr.Dimension taken is within spec.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause remains unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER PERIARTICULAR DISTAL MEDIAL TIBIAL LOCKING PLATE
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6264823
• MDR Text Key: 65349147
• Report Number: 0001822565-2017-00236
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK050121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 00235700710
• Device Lot Number: 63083541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1