MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL REVERSE SHOULDER BASE PLATE CANNULATED DRILL 6M DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-01644 concomitant medical products: trabecular metal reverse shoulder instrumentation pin 2.5 mm diameter pn47430902501 ln63744761.(b)(4).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 the patient underwent a reverse shoulder arthroplasty.During the surgery, as the surgeon was drilling the 6 mm cannulated drill over 2.5 mm pin, the pin fractured at the base of threads.The piece had to be removed from the patient in the middle of the case, delaying the procedure by roughly 30 minutes.No patient impact was reported.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received.The complaint is confirmed based on the returned complaint sample for evaluation.Visual inspection of returned the pin shows fracture at the threads and is jammed within the cannulated drill.The fractured portion of the pin was not returned.The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies relevant to the reported event identified.A definite root cause cannot be determined with the information 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.

Event Description

It was reported that the patient underwent a reverse shoulder arthroplasty.During the surgery, as the surgeon was drilling the 6mm cannulated drill over 2.5 mm pin, the pin fractured at the base of the threads.The piece had to be removed from the patient in the middle of the case, delaying the procedure by roughly 30 minutes.No additional patient impact was reported.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER BASE PLATE CANNULATED DRILL 6M DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7414852
• MDR Text Key: 104964690
• Report Number: 0001822565-2018-01646
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121543
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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: 47430906115
• Device Lot Number: 63788651
• Other Device ID Number: (01) 00889024274297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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): Required Intervention