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

Catalog Number 277268

Device Problem Break (1069)

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

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 initially reports surgeon was performing an anterior cervical fusion.He noticed that the instrument (a rhoton dissector) was missing a part of its tip.X-ray taken at end of procedure was negative for presence of foreign body in the incision site.No harm to patient.

Manufacturer Narrative

(b)(4).Integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation results: failure analysis - there is one rhoton-type hook returned in used condition, showing minimal wear.Inspected the hook and the tip is broken off, this is a very delicate instrument and could have happened while in use or even dropped.This complaint is confirmed/root cause undetermined.Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.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 root cause has not been identified as a workmanship or material deficiency.

• Brand Name: RHOTON-TYPE HOOK 71/2 90D SSHP
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; 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 ; 6099362393
• MDR Report Key: 5062384
• MDR Text Key: 25229505
• Report Number: 2523190-2015-00075
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 09/08/2015
• 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