MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STR RNGLC BTN LTCH INSERTER; INSTRUMENT, HIP

Model Number N/A

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).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 Description

It was reported that during surgery, the shell impactor fractured where it screws into the acetabular shell.The patient retained a foreign body.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

Udi#: (b)(4).The event was confirmed with product returned.Visual inspection confirmed the threaded tip to be fractured.A portion of the face of the rod remains on the tip.The fractured portion was not returned.The shaft of the inserter is scratched and scuffed.Dings were observed on the handle.Impact marks were found on the handle near the strike plate.The common failure mode for the threaded inserter tips is bending overload of the threaded tip, some of which may have also had minimal threads engaged at the time of fracture.Dhr was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: STR RNGLC BTN LTCH INSERTER
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9503745
• MDR Text Key: 172429567
• Report Number: 0001825034-2019-05656
• Device Sequence Number: 1
• Product Code: MDM
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

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: S313152
• Device Lot Number: 268670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR