MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL SCREW 3.5 X 18MM; SCEW, FIXATION

Catalog Number 815037018

Device Problem Material Discolored (1170)

Patient Problem Pain (1994)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: alps distal fibula plate pn: 8162-06-004 lot unk; 3.5x50 non locking screw pn: 1312-18-050 lot: unk; 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk; 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk; 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk; 3.5x16 locking screw pn: 8161-35-016 lot: unk; 3.5x16 locking screw pn: 8161-35-016 lot: unk; 3.5x16 locking screw pn: 8161-35-016 lot: unk; 3.5x14 locking screw pn: 8162-35-014 lot: unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10736, 0001825034-2018-10737, 0001825034-2018-10738, 0001825034-2018-10739, 0001825034-2018-10743, 0001825034-2018-10757, 0001825034-2018-10758, 0001825034-2018-10759, 0001825034-2018-10760, 0001825034-2018-10761.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain.When the incision was made, the surgeon removed both soft tissue around the screw heads.Screws were removed and the surgeon noticed black coloring on the fibula under the plate.

Manufacturer Narrative

Concomitant medical products: alps distal fibula plate pn: 8162-06-004 lot rm145e, 3.5x50 non locking screw pn: 1312-18-050 lot: unk , 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk, 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk, 3.5x14 lp non locking screw pn: 1312-18-014 lot: unk, 3.5x16 locking screw pn: 8161-35-016 lot: unk, 3.5x16 locking screw pn: 8161-35-016 lot: unk, 3.5x16 locking screw pn: 8161-35-016 lot: unk, 3.5x18 non locking screw pn: 8150-37-018 lot: m00501 f, 3.5mm lock com plate pn: 816235014 lot: unk, 3.5 mm cort lock scr 18mm ns pn: 816135018 lot: unk , 3.5 mm cort lock scr 18mm ns pn: 816135018 lot: unk, 3.5 mm cort lock scr 18mm ns pn: 816135018 lot: unk.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 event information available at the time of this report.

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.Complaint sample was evaluated and the reported event was confirmed.9 screws and 1 plate were returned for evaluation.The plate has a few scratches on it most likely from being explanted.3 returned screws are visually conforming to print 816135006 and overall length is conforming.There is damage to the locking threads and even the start of it to sliver.The non-locking threads shows damage to the head some worse than others.Intra-operative photos were provided and confirm the presence of black material where the plate was removed.Device history record 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.

• Brand Name: CORTICAL SCREW 3.5 X 18MM
• Type of Device: SCEW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8077588
• MDR Text Key: 127361615
• Report Number: 0001825034-2018-10760
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 815037018
• Device Lot Number: M00501 F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention