MAUDE Adverse Event Report: ZIMMER GMBH ASSEMBLY FORCEPS; N/A

Model Number N/A

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: zimmer ncb-df drill guide item# 02.00024.061, lot# 16.308835.Zimmer ncb-df drill guide item# 02.00024.061, lot# 14.981829.Product 02.00002.002 is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Device history record (dhr) was reviewed and no discrepancies were found.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

It was reported that the assembly pin for the mis was bent and broke when being used to tighten the drill guide into the plate.Excessive force was required to thread drill guides into plate.No injury to patient and no surgical delay was reported.Attempts to obtain additional information have been made however, no more is available at this point.

• Brand Name: ASSEMBLY FORCEPS
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8339086
• MDR Text Key: 138558638
• Report Number: 0009613350-2019-00069
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.00002.002
• Device Lot Number: 4501774157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• 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