MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7 MM LOCKING SCREW 20 MM LENGTH; SCREW, FIXATION

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problems Unspecified Infection (1930); Irritation (1941); Pain (1994); Swelling (2091)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 47234801635, periarticular screws sterile, 63486170.The 47234801635, periarticular screws sterile, 63085306.The 47482801602, 2.7 mm univ locking scrs st, 63416587.The 47482801202, 2.7 mm univ locking scrs st, 63585778.The 47482801802, 2.7 mm univ locking screws, 63500426.The 47482801802, 2.7 mm univ locking screws, 63500426.The 47234801635, periarticular screws sterile, 63486170.The 47234801435, periarticular screws, 63486167.The 47235701706, periarticular lkng plt fib st, 63202116 (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03168, 0001822565-2018-03169, 0001822565-2018-03170, 0001822565-2018-03171, 0001822565-2018-03172, 0001822565-2018-03167, 0001822565-2018-03174, 0001822565-2018-03175, 0001822565-2018-02639.

Event Description

It was reported that the patient's trauma plate was revised due to redness, soft tissue irritation, pain, infection, and swelling.Upon explantation, it was noted that there was corrosion and discoloration on the plate.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: medical products - 2.0 mm cannula d-drive for use with 3.5 mm / 2.7 mm locking screw, catalog #: 00236002120 lot #: 61235788 qty: 4.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Event date - (b)(6)2017.Reported event was confirmed by review of a picture of the device.No product was returned; visual and dimensional evaluations could not be performed.A picture of the plate is provided.Discoloration is seen on the late.However, without the product, no further evaluations can be performed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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

It was reported that the patient's trauma plate was revised due to redness, soft tissue irritation, pain, infection, and swelling.Upon explantation, it was noted that there was corrosion and discoloration on the plate.Attempts have been made and additional information on the reported event is unavailable.

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: 2.7 MM LOCKING SCREW 20 MM LENGTH
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7588834
• MDR Text Key: 110678088
• Report Number: 0001822565-2018-03173
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: PK070906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47482802002
• Device Lot Number: 62602704
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR