MAUDE Adverse Event Report: BIOMET MICROFIXATION X-DRIVE FOSSA SCREW 2.0MM X 11.0MM TI 6AL 4V ALLOY; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Initial reporter also sent report to fda - the user facility is foreign; therefore a facility medwatch report will not be available.
Event or Problem Description
It was reported that the screw fractured at the head during the attempted insertion.When fixing the fossa component on the left side during a bilateral total arthroplasty of the temporomandibular joint operation, the screw head broke and the surgeon was unable to remove the fractured tip from the patient's bone.The surgeon was able to fixate the fossa implant very well with three screws.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation showed that the screw had fractured near the head where the threaded section begins.The complaint is confirmed.Functional testing was not conducted because the tip of the screw was clearly fractured off.The tip was not returned as it was reported to have been left in the patient's bone.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to damage sustained during the insertion attempt.Potential contributing factors could be the density of the patient's bone and the insertion angle of the screw.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 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: X-DRIVE FOSSA SCREW 2.0MM X 11.0MM TI 6AL 4V ALLOY
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8455669
• Report Number: 0001032347-2019-00187
• Device Sequence Number: 2818863
• Product Code: JEY
• UDI-Device Identifier: 00841036057466
• UDI-Public: 00841036057466
• Combination Product (Y/N): N
• PMA/510(K) Number: K910038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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: Other