MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; SCREW, PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 1.5mm lock plate ty-shape cat# 131220154 lot#ni; unknown screw cat#ni lot#ni.Unknown screw cat#ni lot#ni.Report source: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: plate and screw fixation is present at the proximal first metatarsal.The plate is fractured as well as at least three of the fixation screws.The metatarsal osteotomy is displaced.The fractured screws appear loose.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02736-3, 0001825034-2022-00556 , 0001825034-2022-00558.

Event Description

It was reported that the patient was revised due to a subsided and fractured plate and three fractured screws.The components were used for sphenoid osteotomy of the foot bone.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN SCREW
• Type of Device: SCREW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13773357
• MDR Text Key: 287246452
• Report Number: 0001825034-2022-00557
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 94 KG