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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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 that a screw broke during a procedure.There was a delay of a few minutes while a replacement screw was procured.Attempts have been made and no further information has been provided.
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.The complaint was opened because lauren cucci, csr, reports on behalf of the facility that a screw broke during a procedure.The 2.0x5mm sus push scr 2/pk (part#: 915-2336, lot#: unk) was not returned for evaluation and no photos were provided.For these reasons, the product could not be visually evaluated or functionally tested.The dhr for this product could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (915-2336) and the previous one year (from the notification date), there is a complaint rate of 0.127%, which is already below the occurrence rate of this failure mode.The most likely underlying cause could not 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.

• Brand Name: LACTOSORB SYSTEM 2.0 X 5 MM 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: 8896978
• Report Number: 0001032347-2019-00388
• Device Sequence Number: 13829136
• 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: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-2336
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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