MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RF MODULAR TARG GUIDE MODULE L INSTRUMENT, TRAUMA

Catalog Number 00249000431

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02562, 0001822565-2020-02561, 0001822565-2020-02875. Item# 00249000424; lot# 61793873, item# 00249000432; lot# 63206145, item# 00249000430; lot# 63210804, 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. 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 approximately 3 months ago during an initial surgery, the retrograde nail jig attachment would not line up to the proximal holes. There was a 35 minute delay. Attempts have been made and no further information has been provided.

• Brand Name: RF MODULAR TARG GUIDE MODULE L
• Type of Device: INSTRUMENT, TRAUMA
• 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: 10391972
• MDR Text Key: 202411509
• Report Number: 0001822565-2020-02876
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 00249000431
• Device Lot Number: 63199333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: NI