MAUDE Adverse Event Report: BIOMET MICROFIXATION "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation custom made tmj catalog #: tmjpm-1944, lot #: 812610; biomet microfixation screw catalog #: 91-2714, lot #: unknown; biomet microfixation screw catalog #: 91-2716, lot #: unknown.The user facility is foreign; therefore a facility medwatch report will not be available.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2019-00171, 0001032347-2019-00221 & 0001032347-2019-00222.
Event or Problem Description
It was reported a request for a custom implant was received, indicating that a revision will occur.The revision is planned because the mandible component has become dislocated from the fossa component.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Based on the vendor complaint report, it was determined that the orthognathic movements did not match the vsp, the complaint is confirmed.They proposed this was due to the lefort osteotomy of the maxilla on the postop scan differing from the planned one.No x-rays, scans, photographs, or physician reports were provided.The product was not returned and no functional tests or inspections could be performed.The design vendor reviewed the digital design of the left fossa and mandible implants and marking guides and determined that they fit correctly to the patient's anatomy, the screw hole locations were correct, and the products were therefore conforming to design specifications (470-500).Device history record (dhr) review was unable to be performed as the lot number of the screws involved in the event is unknown.The most likely underlying cause of the complaint cannot be determined.However, it is possible that this may have been due to lefort marking guides not having been requested/provided.Intermediate and final splints were provided, and a digital review by the vendor found them to be conforming to wi 470-906.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" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8516063
• Report Number: 0001032347-2019-00223
• Device Sequence Number: 2798126
• Product Code: HWC
• UDI-Device Identifier: 00841036088873
• UDI-Public: 00841036088873
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 91-2718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: Hospitalization; Required Intervention