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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM CORT LOCK SCR 18MM NS; PLATE, FIXATION
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ZIMMER BIOMET, INC. 3.5MM CORT LOCK SCR 18MM NS; PLATE, FIXATION Back to Search Results
Catalog Number 816135018
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 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, 0001825034-2019-00889, 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 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
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 Description
No further event information available at the time of this report.
 
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Brand Name
3.5MM CORT LOCK SCR 18MM NS
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8385753
MDR Text Key137668160
Report Number0001825034-2019-00887
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K082300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Catalogue Number816135018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/19/2018
Initial Date FDA Received03/04/2019
Supplement Dates Manufacturer Received04/25/2019
Supplement Dates FDA Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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