MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SWIVEL RATCHET SHAFT; INSTRUMENT, HIP

Model Number N/A

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(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 a patient underwent an initial left hip procedure.Subsequently, the doctor was inserting a screw into a cup, and the screw would not seat properly.When he tapped the screwdriver handle with a mallet, the tip of the screwdriver broke off in the screw head.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that it is in good overall condition outside of the fracture.The hex feature is fractured.The fractured portion of the hex bit was not returned as the complaint description states it was retained within the patient.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Review of complaint history determined that no further action(s) is/are required.Investigation results concluded the most likely root cause is determined to be use error, as the screwdriver is designed for torsional force, and not impaction force.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 a patient underwent a left hip procedure.Subsequently, while the doctor was inserting a screw into a cup, the screw would not seat properly, so the surgeon impacted the screwdriver handle with a mallet.As a result, the tip of the screwdriver broke off in the screw head.There was a ten (10) minute delay to the procedure to try and remove the fractured tip, however it was unable to be retrieved so it was left in the screw head.The fractured piece was reportedly not interfering with the liner and sat flush in the cup.No further patient consequences were reported.

• Brand Name: SWIVEL RATCHET SHAFT
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 6808374
• MDR Text Key: 83238854
• Report Number: 0001825034-2017-06156
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• 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: 420047
• Device Lot Number: 178860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2011
• 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): Other
• Patient Age: 65 YR