MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO BIMETRIC STEM INSERTER; INSTRUMENT, HIPS

Model Number	31-555619
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat# 192410 lot# 417580r echo por fmrl red nc 10x130mm.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial hip surgery, the stem inserter threads snapped off after one mallet strike while attempting to implant the stem.The broken threads were lodged inside the implant.There was no way to get the broken threads out, and no way to screw a new inserter into the stem.Therefore, the implant was wasted, and a new one was used.It was reported that the implant itself was not defective, but the inserter (instrument) may have been.Surgical technique was utilized.There was no patient impact.There was no medical or surgical intervention.There was no surgical delay and no surgical complications.Foreign body was not retained.There were no contributing conditions related to the event.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d9;g3;h2;h3;h6 one inserter was returned and evaluated.A visual inspection the device showed scuffing to both the inner and outer shafts.The blue handle had scuffing and scratches.There were also indentations to the strike plate.The threaded tip of the device was fractured with wear lines visible on two spots of the shaft, with one near the fracture site.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.The reported event was confirmed via the returned product.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: ECHO BIMETRIC STEM INSERTER
• Common Device Name: INSTRUMENT, HIPS
• 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: 19360175
• Report Number: 0001825034-2024-01311
• Device Sequence Number: 15038448
• Product Code: LXH
• UDI-Device Identifier: 00880304466296
• UDI-Public: (01)00880304466296(11)191014(10)381280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 31-555619
• Device Lot Number: 381280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown