MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.5MM LOCK PLATE TY-SHAPE; PLATE, FIXATION, BONE

Model Number N/A

Device Problems Fracture (1260); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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.

Event Description

It was reported that a patient's implant subsided.The components were used for sphenoid osteotomy of the foot bone.Attempts have been made and there is no further information at this time.

Event Description

It was further reported that the plate fractured as well as 3 screws.

Manufacturer Narrative

(b)(4) d10 - medical product: catalog #: unknown, plascrewte, lot # unknown catalog #: unknown, screw, lot # unknown catalog #: unknown, screw, lot # unknown 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: 0001822565-2021-03095, 0001822565-2021-03096, 0001822565-2021-03097.

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001822565-2021-03279.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001822565-2021-03279.

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.

Manufacturer Narrative

(b)(4).D10: unknown screw cat#ni lot#ni, unknown screw cat#ni lot#ni, unknown screw cat#ni lot#ni.G2: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not 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: 0001825034-2022-00556, 0001825034-2022-00557, 0001825034-2022-00558.

• Brand Name: 1.5MM LOCK PLATE TY-SHAPE
• Type of Device: PLATE, FIXATION, BONE
• 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: 12541552
• MDR Text Key: 273647723
• Report Number: 0001825034-2021-02736
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K081546
• 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,Followup,Followup,Followup
• Report Date: 03/15/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 131220154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 10/01/2021; 11/01/2021; 03/03/2022
• Supplement Dates FDA Received: 10/25/2021; 11/12/2021; 03/15/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Weight: 94 KG