MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FIBULAR PLATE RIGHT 6 HOLES 106 MM LENGTH; PLATE, FIXATION, BONE

Catalog Number 47235701706

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed in association with this event: 0001822565 - 2019 - 00642, 0001822565 - 2019 - 00644, 0001822565 - 2019 - 00646, 0001822565 - 2019 - 00650, 0001822565 - 2019 - 00651, 0001822565 - 2019 - 00652, 0001822565 - 2019 - 00653, 0002648920 - 2019 - 00105, 0002648920 - 2019 - 00106, 0002648920 - 2019 - 00107.(b)(4).Concomitant medical products: 47235701706 distal lateral fibular plate right 6 holes 106 mm length lot 63120589, 47235901238 3.5 mm locking screw with 2.7 mm head 12 mm length lot 63094822, 47235901838 3.5 mm locking screw with 2.7 mm head 18 mm length lot 63162401, 47235901438 3.5 mm locking screw with 2.7 mm head 14 mm length lot 63610822, 47235901838 3.5 mm locking screw with 2.7 mm head 18 mm length lot 63133353, 47235901438 3.5 mm locking screw with 2.7 mm head 14 mm length lot 61155743, 47235901638 3.5 mm locking screw with 2.7 mm head 16 mm length lot 63207723, 47234802235 cortical bone screw self-tapping hex head 3.5 mm diameter 22 mm length lot 63001757, 47234801435 cortical bone screw self-tapping hex head 3.5 mm diameter 14 mm length lot 63098015, 47234803035 cortical bone screw self-tapping hex head 3.5 mm diameter 30 mm length lot 61168837.Foreign; the event occurred in the (b)(6).The devices were discarded at the site and will not be returned for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that the patient had a revision to remove the plate and it was identified the plate was sitting proud.No delay to surgery, medical intervention, or patient consequence was reported as a result of this issue.No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as no device was returned.Device history record (dhr) review identified no related manufacturing deviations or anomalies.Root cause is unknown.A batch examination of devices with related issues was performed.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 the related issue complaint device history records 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 available at the time of this reporting.

• Brand Name: DISTAL LATERAL FIBULAR PLATE RIGHT 6 HOLES 106 MM LENGTH
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8339404
• MDR Text Key: 136142452
• Report Number: 0001822565-2019-00642
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K070906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47235701706
• Device Lot Number: 63120589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 30 YR