MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW; SCREW, FIXATION, BONE

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional 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: 62348896.2.7 mm locking screw 18 mm length, pn: 47482801802, ln: 63861772.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 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, 0001822565-2019-00660, 0001822565-2019-00662, 0001822565-2019-00663, 0001822565-2019-00664, 0002648920-2019-00109, 0002648920-2019-00108.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 or Problem Description
It was reported that the patient underwent a revision due to apparent infection.It was further reported that a screw backed out.No further information is available at this time.

• Brand Name: CORTICAL BONE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9185153
• Report Number: 0002648920-2019-00738
• Device Sequence Number: 3031214
• Product Code: HWC
• UDI-Device Identifier: 00889024087668
• UDI-Public: (01)00889024087668
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 47234801235
• Device Lot Number: 63406688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR