MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0X6MM CROSS-DRIVE SCREW; BONE SCREW

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/06/2019
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.Concomitant medical products: zimmer biomet cross-drive screw, catalog #: 41-2008, lot #:ni, zimmer biomet traumaone plate, catalog #: sp-2376, lot #:ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00250 and 0001032347-2019-00252.
Event or Problem Description
It was reported that a plate fractured approximately six weeks after implantation.A revision to remove the fractured plate and the screws used to fixate the plate was scheduled to take place on (b)(6) 2019, however confirmation of the revision has not been received.Attempts have been made and no further information has been provided.
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.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.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: TRAUMAONE SYSTEM 2.0X6MM CROSS-DRIVE SCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8554655
• Report Number: 0001032347-2019-00251
• Device Sequence Number: 360907
• Product Code: JEY
• UDI-Device Identifier: 00841036124601
• UDI-Public: 00841036124601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 41-2006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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