MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 0 MM RASP LONG POST SIZE 4; HIPS, INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported the patient came in for a follow up visit and x-rays showed a broken tip of an instrument.It appears the tip of a size 4 rasp broke and remains inside of the patient.No additional surgery will take place to remove the broken piece.

Manufacturer Narrative

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

Event Description

No additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- rasp.Visual examination of the returned product identified approximately.400¿ of the distal end is fractured and missing.The cutting edges exhibit damage / wear & tear that indicates repeated use during a potential field age greater than 8 years.The rasp was submitted for further analysis.Analysis determined fracture surface artifacts suggest the bending fatigue failure mode with several possible initiations around the perimeter.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: metallic object consistent with a fractured instrument tip within the femoral medullary canal.A definitive root cause cannot be determined.This complaint was confirmed based on the returned device and x-rays.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 0 MM RASP LONG POST SIZE 4
• Type of Device: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17652202
• MDR Text Key: 322307078
• Report Number: 0001822565-2023-02363
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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: 00771200464
• Device Lot Number: 62525229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male