MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR INSERTER HANDLE THREAD 1/4-28; INSTRUMENT, HIP

Catalog Number 110024782

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2019

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.Udi# (b)(4).

Event Description

It was reported that the during a hip revision surgery the inserter handle would not disengage from the stem, as the surgeon attempted to loosen the handle the inner shaft broke free from the stem leaving the threaded tip of the inserter inside the stem.Subsequently, the patient retained the foreign object.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was able to be confirmed by visual examination of the returned device.Upon visual inspection the threaded tip of the device had fractured.There is no visible damage to the remaining shaft and the threaded portion was not returned dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: MODULAR INSERTER HANDLE THREAD 1/4-28
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9595554
• MDR Text Key: 175189512
• Report Number: 0001825034-2020-00256
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110024782
• Device Lot Number: 978710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 67