MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM 2.0 X 5MM SUSPENSION PUSH SCREW; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
It was reported that the screw fractured during a surgery.The fractured piece was removed.Attempts have been made and no further information has been provided.No additional patient consequences were reported.
Additional Manufacturer Narrative
Date received by manufacturer was initially reported incorrectly as jun 04, 2019.The date the manufacturer was made aware of this issue was jun 03, 2019 and so the correct entry for date received by manufacturer is jun 03, 2019.
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.The complaint cannot be verified based on the information and materials provided.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, ct scans or physician reports being provided.The dhr was reviewed and there were no non-conformances found.There is no indication of manufacturing defects.The most likely underlying cause of the complaint cannot be determined.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: LACTOSORB SYSTEM 2.0 X 5MM SUSPENSION PUSH SCREW
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8762690
• Report Number: 0001032347-2019-00345
• Device Sequence Number: 11404580
• Product Code: MBI
• UDI-Device Identifier: 00841036055332
• UDI-Public: 00841036055332
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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 Expiration Date: 01/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2336
• Device Lot Number: 030020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 09/10/2019; 06/03/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 09/10/2019; 09/18/2019
• 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: Required Intervention