MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RONGEUR,UNKNOWN; N/A

Catalog Number XXX-RUGGLES RONGEUR,

Device Problem Device Fell (4014)

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

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device involved will be returned to the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Sus voluntary event report foi for manufacturers (mw5082255) was received on 14jan2019 with the following information: on (b)(6) 2018, a surgical tech noted that a screw of the 260-504 ruggles redmond was missing (measured about 5mm in diameter and several 8mm in length) during a hip arthroplasty surgery.An xray was taken to confirm the screw had fallen into the posterior soft tissues.The device was in contact with the patient.There is no information provided regarding patient injury or death alleged and delay in the surgery.Additional information has been requested but no clinical information has been provided.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation.Product has not been returned.The reported complaint is unconfirmed.

• Brand Name: RONGEUR,UNKNOWN
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8319939
• MDR Text Key: 135514531
• Report Number: 2523190-2019-00018
• Device Sequence Number: 1
• Product Code: HTX
• 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: 01/14/2019

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: XXX-RUGGLES RONGEUR,
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1