MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERIARTICULAR SCREWS; 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 Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).Event date - (b)(6) 2017.(b)(4).Concomitant medical products- 47234801635, periarticular screws sterile, 63486170, qty: 2, 47234801635, periarticular screws sterile, 63085306, 47482801602, 2.7mm univ locking scrs st, 63416587, 47482801202, 2.7mm univ locking scrs st, 63585778, 47482801802, 2.7mm univ locking screws, 63500426, 47482801802, 2.7mm univ locking screws, 63500426, 47482802002, 2.7mm univ locking screws, 62602704, 47235701706, periarticular lkng plt fib st, 63202116.Report source, foreign - the event occurred in the (b)(6).Multiple mdr reports were filed for this event, 0002648920-2018-00764, 0002648920-2018-00765, 0002648920-2018-00766, 0001822565 - 2018 - 03170, 0001822565 - 2018 - 03171, 0001822565 - 2018 - 03172, 0001822565 - 2018 - 03173, 0001822565 - 2018 - 03175, 0001822565 - 2018 - 02639.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.

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.Concomitant 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 information available at the time of this reporting.

Manufacturer Narrative

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.

• Brand Name: PERIARTICULAR SCREWS
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8003145
• MDR Text Key: 124944517
• Report Number: 0002648920-2018-00767
• 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,Followup
• Report Date: 11/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47234801435
• Device Lot Number: 63486167
• 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