MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00529, 0001032347-2019-00530, 0001032347-2019-00531, 0001032347-2019-00532.Implantation date was in (b)(6) 2019 concomitant medical products: 2.4mm locking recon system 5x22 angle lock recon plate, right; part# 24-4543; lot# 607960; 2.4mm locking recon system ht cross-drive locking recon screw,5/pk; part# 85-2508, lot# 453890; 2.4mm locking recon system ht cross-drive locking recon screw,5/pk; part# 85-2510; lot# 808880; 2.4mm locking recon system ht cross-drive locking recon screw,5/pk, part# 85-2516; lot# 333980.Initial reporter: the user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).

Event Description

It was reported the patient is experiencing facial redness and swelling.The patient underwent a mandibular reconstruction in (b)(6) 2019 following a tumor resection.Allergic reaction or infection are suspected but neither are confirmed.The patient has weakened immunity due to drug therapy and radiation.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The 2.4mmx16mmht xdr lck rcn sc5pk (part# 85-2516, lot# 333980) was not returned for investigation; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The dhr for this product was reviewed; no non-conformances were found.There are no indications of manufacturing defects.For this part (85-2516) and the previous one year (from the notification date) regarding redness and swelling post-op, there is a complaint rate of 0.30% which is no greater than the occurrence listed in the application fmea.This is the only complaint regarding redness or swelling for this part# 85-2516, lot# 333980.The most likely underlying cause cannot be determined from the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: 2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9429243
• MDR Text Key: 169729612
• Report Number: 0001032347-2019-00532
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036060053
• UDI-Public: 00841036060053
• Combination Product (y/n): N
• PMA/PMN Number: K113512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 85-2516
• Device Lot Number: 333980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention