MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RHOTON-TYPE HOOK 71/2 90D SSHP

Catalog Number 277268

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer medwatch #5041705 reports surgeon was performing an anterior cervical fusion, he noticed that the instrument (a rhoton dissector) was missing a part of it's tip.X-ray was taken at the end of procedure and was negative for presence of foreign body in the incision site.No harm to patient.

Manufacturer Narrative

On (b)(6) 2015 integra completed investigation.This hook was manufactured at least 15 years ago.The exact manufacturing date is unknown.Method: failure analysis, device history evaluation.Results: failure analysis - the returned hook showing wear.Upon visually inspecting it is confirmed that the tip is broken.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the complaint is confirmed: root cause undetermined.No manufacturing deficiency has been found.

• Brand Name: RHOTON-TYPE HOOK 71/2 90D SSHP
• Type of Device: NA
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 8006542873
• MDR Report Key: 4938378
• MDR Text Key: 22725781
• Report Number: 2523190-2015-00043
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 06/26/2015,08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 277268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 06/26/2015
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR