MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MONOBLOCK INSERTER HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Infiltration into Tissue (1931)

Event Date 07/14/2019

Event Type  Injury  

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 during a development lab training, a stem was implanted into a stripped femur.While attempting to remove the stem from the inserter handle, the threaded distal tip fractured and remained lodged in the stem.An osteotomy was then performed in order to remove the stem component.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi : (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device notes threads had fractured inside of the stem which was alos returned.There are impact marks on the shaft towards the rubber handle.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to off label usage and failure to follow surgical technique as the implant and instruments are not compatible.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

No additional event information to report at this time.

• Brand Name: MONOBLOCK INSERTER HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8864251
• MDR Text Key: 153375615
• Report Number: 0001825034-2019-03421
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110024780
• Device Lot Number: 656480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 11-300814 ¿ ARCOS STEM ¿ 330040; 11-300814 ¿ ARCOS STEM ¿ 330040
• Patient Outcome(s): Hospitalization; Required Intervention