MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X26MM LOW PRO CORT SCR STE; PROSTHESIS, TRAUMA, SCREW

Catalog Number 851235026

Device Problem Fracture (1260)

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

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item#: 851218000, lot# 312410.Report source: foreign - event occurred in japan.Product has been received by zimmer biomet and 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

It was reported that during the surgery, the screw had fractured off below the head after implantation.Subsequently, the screw shaft remained in the patient's body but no consequences were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device has fractured and not all the pieces were returned.The returned device was reviewed with scanning electron microscopy and showed sheared ductile overload dimples moving in opposite directions (rotating around the fracture surface), with the middle of the fracture surface showing tensile ductile overload dimples.These fracture surface artifacts suggest the torsional overload mode of failure.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: 3.5X26MM LOW PRO CORT SCR STE
• Type of Device: PROSTHESIS, TRAUMA, SCREW
• 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: 15211869
• MDR Text Key: 305167942
• Report Number: 0001825034-2022-01847
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868352454
• UDI-Public: (01)00887868352454(17)280619(10)096410
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 851235026
• Device Lot Number: 096410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose