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

Catalog Number 277269

Device Problem Break (1069)

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

Event Date 08/19/2015

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

Medwatch mw5055958 initially reports a micro dissector tip broke off inside of the surgical site.Doctor was able to locate and remove the broken tip.The tip and the instrument were immediately removed from the sterile field.No harm done.

Manufacturer Narrative

On 12/15/2015 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis: complaint is unconfirmed; this is due to the product not being returned for review.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: root cause cannot be determined due to the lack of information received to perform a complete investigation.

• Brand Name: RHOTON-TYPE HOOK 71/2 90D BLT
• 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: 5212036
• MDR Text Key: 30835949
• Report Number: 2523190-2015-00119
• 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
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

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: 277269
• Device Lot Number: NKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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