MAUDE Adverse Event Report: BIOMET TRAUMA CAPTURED HIP SCREW LAG SCREW; PLATE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same patient (reference 0001825034-2017-03013).Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that during a dynamic hip compression screw surgery, the plate would not slide over the screw, resulting in removal of both implants and insertion of new implants.This caused a thirty (30) minute delay in surgery.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This device is not distributed by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k150818.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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: CAPTURED HIP SCREW LAG SCREW
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6539768
• MDR Text Key: 74304964
• Report Number: 0001825034-2017-03010
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK150818
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 945900095
• Device Lot Number: AT1300105
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2013
• 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