MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DUAL TAPER, SPACER IMPACTOR; INSTRUMENT, EXTREMITY

Model Number N/A

Device Problem Fracture (1260)

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

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 instrument threads fractured.No patient injury was reported.Attempts have been made and no further information has been made available at this time.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the threads broke, and the fractured piece fell into the patient and had to be retrieved.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned device confirms the reported instrument fracture as well as obvious impactions marks on the strike plate.Scanning electron microscopy determined the visible fracture artifacts on both fracture surfaces suggest a possible bending overload fracture may have occurred near the thread start.Hardness testing found the device conformed to its specifications.Review of product/lot code combination device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.The reported and observed issue was previously identified and a print specification update was made.Definitive conclusions can't be drawn about the root cause of the reported issue as the returned device was found to be conforming for measurements taken and the service life of the instrument was 10+ years.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: DUAL TAPER, SPACER IMPACTOR
• Type of Device: INSTRUMENT, EXTREMITY
• 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: 7328791
• MDR Text Key: 102211852
• Report Number: 0001822565-2018-01441
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00430903900
• Device Lot Number: 60902334
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention