MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERI SCR 4.0MMX60MMLG FULL THR; PLATE, FIXATION

Catalog Number 00234702260

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not available for return.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 fixation of a plate, the threads of the screw were damaged due to the angle of implantation causing it to run into another screw.The screw was removed and a new one was used to complete the surgery.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed by visual examination of the provided images of the device, which identified damage to the screw.A review of the device history records could not be performed as the lot identification was not provided.The root cause of the reported issue is attributed to use-error, as it was stated that the surgeon deviated from the implantation angle which cause the collision of the screws.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 additional information at the time of this report.

• Brand Name: PERI SCR 4.0MMX60MMLG FULL THR
• Type of Device: PLATE, FIXATION
• 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: 12916955
• MDR Text Key: 281742842
• Report Number: 0001822565-2021-03411
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00234702260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 67 YR
• Patient Sex: Male