MAUDE Adverse Event Report: INTEGRA YORK, PA INC. HOHMANN RETR 25MM WIDE; N/A

Catalog Number 225453

Device Problem Break (1069)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that on (b)(6) 2019, a 225453 hohmann retr 25mm wide blade tip broke during knee surgery.The blade tip was stuck in the knee, and was unable to be removed by the doctor.The doctor tried to retrieve the broken tip for three (3) hours.Additional information was received on (b)(6) 2019; stated that the device tip broke off into the patient¿s knee.Patient injury reported.The action that was taken after the product problem occurred was that the doctor attempted to retrieve the tip of the hohmann.The tip of the hohmann was left in the patient as it could not be retrieved.The revision or medical intervention reported was that the surgical case was extended for 3 hours.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.There were no deviations or non-conformances during the manufacturing process.A failure analysis and determination of root cause is not possible because the product has not been returned.Device identifier: (b)(4).

• Brand Name: HOHMANN RETR 25MM WIDE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8319938
• MDR Text Key: 135512209
• Report Number: 2523190-2019-00019
• Device Sequence Number: 1
• Product Code: GAD
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 225453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1