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
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Swelling (2091); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional 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.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The 2.4mmx10mmht xdr lck rcn sc5pk (part# 85-2510, lot# 808880) 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 (85-2510) and the previous one year (from the notification date) regarding redness and swelling post-op, there is a complaint rate of 0.02% which is no greater than the occurrence listed in the application fmea.This is the only complaint regarding redness or swelling for this part# 85-2510, lot# 808880.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.
Event or Problem 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
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9429233
• Report Number: 0001032347-2019-00531
• Device Sequence Number: 448200
• Product Code: HWC
• UDI-Device Identifier: 00841036058753
• UDI-Public: 00841036058753
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 85-2510
• Device Lot Number: 808880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 04/24/2020
• 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: Required Intervention