MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM CORT LOCK SCR 18MM NS; PLATE, FIXATION

Catalog Number	816135018
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.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, 0001825034-2019-00887, 0001825034-2019-00890.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 or Problem 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.
Additional 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 (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: 3.5MM CORT LOCK SCR 18MM NS
• Common Device Name: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8385761
• Report Number: 0001825034-2019-00889
• Device Sequence Number: 12811277
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K082300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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 Catalogue Number: 816135018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention