MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7MM LOCKING SCREW 18MM LONG; TRAUMA, FIXATION

Catalog Number 47482801802

Device Problem Corroded (1131)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06472, 0001822565-2018-06791, 0002648920-2018-00858 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision procedure due to soft tissue irritation and swelling.During removal of plate it was identified that there appeared to rust or discolouring on the plate and the screws.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

Udi# (b)(4).Following the removal of contamination on the devices, scanning electron microscopy identified isolated pitting corrosion at the screw plate interface constrained to the locking threads of the plate and the screws.The isolated pitting was not identified in other locations of the locking plates and screws, including the discolored areas surrounding the holes from which the tissue deposits were removed.Review of device history record did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.The analysis confirms the device and it¿s materials are conforming to specifications.Root cause is unable to be determined at this time.The device labeling states that in-vivo implant corrosion is a possible adverse effect that may be anticipated as the device is implanted in a corrosive environment.Occurrence rates are within the expected rates therefore; no further action is needed at this time.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.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.X-rays provided were reviewed and noted the overall fit and the alignment of the implant is appropriate.Also noted overlying bimalleolar soft tissue swelling.The newly received information does not change the root cause of the previous investigation.

• Brand Name: 2.7MM LOCKING SCREW 18MM LONG
• Type of Device: TRAUMA, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8146136
• MDR Text Key: 129758094
• Report Number: 0001822565-2018-06794
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K063303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 47482801802
• Device Lot Number: 62545691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR