MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW CANCELLOUS CROSS-DRIVE LOCKING; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2019
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.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 the eight screws fractured or bent during insertion for a sternal closure.The fractured screw fragments remain embedded in the patients bone.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint was confirmed.The scrw 2.4x18mm cancelous lockng (part# 73-2418, lot# unk, qty 6), scrw 2.4x20mm cancelous lockng (part# 73-2420, lot# unk, qty 1), and scrw 2.7x16mm cancelous lockng (part# 73-2716, lot# unk, qty 1) were returned for investigation.It was reported that eight 73-2418 screws were being returned; however, it was determined that one of the returned screws was actually 20mm and therefore part# 73-2420 and another screw was magenta and determined to be part# 73-2716.Visual evaluation of the screws showed that three of the 73-2418 screws were returned fractured near the start of the bone threads, just below the locking threads.The other three 73-2418 screws appeared to be in decent overall condition, with some minor deformation on the threads and cross drive interface.Functional testing was not conducted on these screws because three were fractured and the three others exhibited signs of an insertion attempt, which likely compromised the integrity of the screws.The dhr's for these components could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For this part (73-2418) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of 0.032% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is that the screws experienced excessive force during an insertion attempt, beyond what they are designed to encounter.Over torquing the screws or attempting to insert the screw into a patient with high bone density may have also contributed to the failures.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00506, 0001032347-2020-00096, 0001032347-2020-00097 d11: medical products: sternalock blu system screw, cancellous cross-drive locking, part# 73-2420, lot# unk sternalock blu system screw, cancellous cross-drive locking, part# 73-2418, lot# unk sternalock blu system screw, cancellous cross-drive locking, part# 73-2716, lot# unk the following fields were updated: b4 date of this report b5 describe event or problem d10 device availability d11 medical products g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: STERNALOCK BLU SYSTEM SCREW CANCELLOUS CROSS-DRIVE LOCKING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9372145
• Report Number: 0001032347-2019-00506
• Device Sequence Number: 2902399
• Product Code: HRS
• UDI-Device Identifier: 00841036147587
• UDI-Public: 00841036147587
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 73-2418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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