MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR,1.5 X 5 MM, 5/PK; FASTENER, SCREW, CRANIOPLASTY

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device product code: hbw.Report source - foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported three (3) screws fractured during a procedure.Two fragments out of the three screws fractured at the medium point of the threaded part and both fragments remained in the patient body, and one screw squashed the tip.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 unable to be confirmed due to limited information received from the customer.No product was returned and no functional tests or inspections could be performed.No pictures were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Potential contributing factors could be patient bone density and angle of screw insertion.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.

• Brand Name: 1.5 SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR,1.5 X 5 MM, 5/PK
• Common Device Name: FASTENER, SCREW, CRANIOPLASTY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8437870
• Report Number: 0001032347-2019-00184
• Device Sequence Number: 11209029
• Product Code: HBW
• UDI-Device Identifier: 00841036056667
• UDI-Public: 00841036056667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 95-6105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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: Other; Required Intervention