MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF FEMORAL SLAP HAMMER; PROSTHESIS, KNEE

Model Number N/A

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, number 1 states, ¿when handling sharp instruments use extreme caution to avoid injury.¿.

Event Description

It was reported that a partial knee arthroplasty occurred on (b)(6) 2015.During the procedure, the tip of the surgical assistant's finger was cut on the slap hammer.The assistant went to the emergency department and the cut was treated with gauze tape.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device was unable to confirm the reported complaint.Root cause of the event was most likely attributed to surgical technique or not being familiar with the instrument or warnings in the ifu.

• Brand Name: OXF FEMORAL SLAP HAMMER
• Type of Device: PROSTHESIS, KNEE
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5399850
• MDR Text Key: 37178242
• Report Number: 0001825034-2016-00279
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician Assistant
• Device Model Number: N/A
• Device Catalogue Number: 32-422365
• Device Lot Number: ZB110301
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2011
• 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): Required Intervention
• Patient Age: 54 YR