MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCRWE 1.5 X 4 MM; FASTENER, SCREW, CRANIOPLASTY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Device product code: hbw.Report source: foreign country is (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00138 and 0001032347-2019-00139.
Event or Problem Description
It was reported a revision occurred due to infection.The implant was removed due to streptococcus anginosus infection a month after implantation.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of evidence that the revision was performed.No product was returned and no inspection could be performed.No x-rays, scans, pictures, or physician's reports were provided.Dhr was reviewed and no discrepancies were found.The sterile certificate of the htr-pmi implant were reviewed and there was no anomalies found.Root cause was unable to be determined.There was nothing to indicate that the infection is related to these implants or there was an alleged malfunction of these implants.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00139-1 & 0001032347-2019-00138-1.

• Brand Name: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCRWE 1.5 X 4 MM
• Common Device Name: FASTENER, SCREW, CRANIOPLASTY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8394281
• Report Number: 0001032347-2019-00140
• Device Sequence Number: 2887798
• Product Code: HBW
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K121624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6704
• Device Lot Number: 092700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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
• Patient Age: 15 YR
• Patient Weight: 48