MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER

Model Number	180554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign source: uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a comprehensive reverse shoulder replacement one of the locking peripheral screws fractured while being implanted into the patient.On backing the screw out, it sheered off the head of the screw.The remaining part of the screw was not able to be removed and was secured in the glenoid behind the baseplate.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of pictures.Visual examination of the provided pictures identified the screw has fractured a couple threads below the screw head.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X35 ST
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15337132
• Report Number: 0001825034-2022-01990
• Device Sequence Number: 6889755
• Product Code: MBF
• UDI-Device Identifier: 00880304677173
• UDI-Public: (01)00880304677173(17)311222(10)161040
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 180554
• Device Catalogue Number: 180554
• Device Lot Number: 161040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT: 010000589 COMP RVRS 25MM BSPLT HA+ADPTR R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown