MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X30 ST; PROSTHESIS, SHOULDER

Model Number 180553

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 11/04/2022

Event Type  Injury  

Event Description

It was reported that during implantation of a locking screw as part of comprehensive reverse procedure, the screw broke.The screw was inserted into the baseplate but it got stuck before it was able to lock into the baseplate.Surgeon then tried to back the screw out to re-drill the hole but the screw yielded and fractured.The fractured piece was retained, and surgery was completed as normal.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2022 -02553.Device remains implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures.Visual examination of the provided photograph identified that the screw is broken.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 Description

No further event information is available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X30 ST
• Type of Device: 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: 15784275
• MDR Text Key: 303566317
• Report Number: 0001825034-2022-02552
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304677166
• UDI-Public: (01)00880304677166(17)320717(10)805900
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 180553
• Device Catalogue Number: 180553
• Device Lot Number: 805900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 02/06/2023; 04/04/2023
• Supplement Dates FDA Received: 02/06/2023; 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 010000589 729890 COMP RVRS 25MM BSPLT HA+ADPTR.
• Patient Outcome(s): Other