MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIPASS DISPOSABLE NITINOL 10 PK; PUSHER, SOCKET

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (b)(6).Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Hospital discarded as biohazard.

Event Description

It was reported that during a rotator cuff repair, the nitinol pusher fractured inside of the patient, causing the surgeon to have to retrieve the broken piece.No further patient consequences were reported.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.Reported event was confirmed by review of photos.Two pictures are provided for evaluation.The tip of the nitinol pusher shaft appears to be fractured.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: BIPASS DISPOSABLE NITINOL 10 PK
• Type of Device: PUSHER, SOCKET
• 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: 7082027
• MDR Text Key: 93682797
• Report Number: 0001825034-2017-10774
• Device Sequence Number: 1
• Product Code: HXO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 902094
• Device Lot Number: 834650
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention