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

Catalog Number 47482801802

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Infection (1930)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length pn: 47235701806 ln: 63550687; 2.7 mm locking screw 14 mm length pn: 47482801402 ln: 63671062; 2.7 mm locking screw 16 mm length pn: 47482801602 ln: 63869781; 2.7 mm locking screw 12 mm length pn: 47482801202 ln: 63861780; 2.7mm locking screw 12mm long pn: unk ln: 62348896; cortical bone screw self-tapping hex head 3.5 mm diameter 18 mm length pn: 47234801835 ln: 63098016; cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688; cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length pn: 47234801235 ln: 63406688 ; cortical bone screw self-tapping hex head 3.5 mm diameter 40 mm length pn: 47234804035 ln: 61168845; cortical bone screw self-tapping hex head 3.5 mm diameter 46 mm length pn: 47234804635 ln: 61214651.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00655, 0001822565-2019-00656, 0001822565-2019-00657, 0001822565-2019-00658, 0001822565-2019-00659, 0001822565-2019-00662, 0001822565-2019-00663, 0001822565-2019-00664, 0002648920-2019-00109, 0002648920-2019-00108.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision due to screw backing out and alleged infection.However, there was no growth from three samples.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 available at the time of this reporting.

• Brand Name: 2.7 MM LOCKING SCREW 18 MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8348337
• MDR Text Key: 136486755
• Report Number: 0001822565-2019-00660
• 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
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47482801802
• Device Lot Number: 63861772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR