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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The complaint was confirmed.The screw 2.4 x 18mm cancelous lockng (part # 73-2418, lot # unk, qty 6), scrw 2.4 x 20mm cancelous lockng (part # 73-2420, lot # unk, qty 1), and scrw 2.7 x 16mm 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 screw showed that the 73-2420 was severely damaged and had an obvious bend in the shaft, damage in a few locations in the threads, and damage to the head of the screw and cross drive interface.Functional testing was not conducted on this screw as it was visibly bent, which likely compromised the integrity of the screw.The dhr for this component could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (73-2420) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of 0.024% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is that the screw experienced excessive force during an insertion attempt, beyond what it is designed to encounter.The bent screw shaft indicates that there was excessive force applied off axis during the insertion attempt.Over torquing the screw or attempting to insert the screw into a patient with high bone density may have also contributed to the failure.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, 0001032347-2020-00097.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.
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 patient's bone.No additional patient consequences were reported.

• 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: 9689591
• Report Number: 0001032347-2020-00096
• Device Sequence Number: 3392955
• Product Code: HRS
• UDI-Device Identifier: 00841036147594
• UDI-Public: 00841036147594
• 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
• 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: 73-2420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial 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