MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE AUGMENT REAMER GUIDE - SMALL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as product location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an augmented reverse shoulder procedure, the bushing was not used during reaming through the drill guide, which resulted in the reamer striking the baseplate drill guide and fracturing it.All pieces were recovered from the patient.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to limited information received from the customer.A device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.It was reported that the surgeon did not use the bushing on the guide as required per the surgical technique.Per the surgical technique, it states, ¿once the 3.5 mm hex driver has been removed, insert the reamer guide bushing onto the reamer guide post and make sure it is completely down.¿ as the surgical technique was not followed, the root cause is determined to be use error.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: COMPREHENSIVE AUGMENT REAMER GUIDE - SMALL
• 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: 7543187
• MDR Text Key: 109228773
• Report Number: 0001825034-2018-03635
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110040210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR