MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ALLIS TISS FCPS 6 5X6T; N/A

Catalog Number 135105

Device Problem Break (1069)

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

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

The customer initially reports this instrument is broken from the boxlock during general surgery.No broken parts inside the patient.On 3/11/16 dealer reports the shank broken.No harm done.

Manufacturer Narrative

On 5/4/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer.The instrument was not returned for further evaluation.Device history evaluation - dhr review was completed with all history available.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.The instrument was not returned for further evaluation.

Manufacturer Narrative

11/8/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - forceps returned in used condition, not showing any unusual markings.The returned forceps showing wear, staining, and a broken jaw.During the evaluation of the instrument, it is noticed that there is rust formation where the breakage appears to be.It appears the breakage may have started out as a fracture leading to the breakage.It is also noticed that the jaw is broken., the cause is undetermined.The complaint is confirmed.Device history evaluation - dhr review was completed with all history available.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: ALLIS TISS FCPS 6 5X6T
• 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: 5520022
• MDR Text Key: 41024711
• Report Number: 2523190-2016-00039
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2016

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: 135105
• Device Lot Number: 8859113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/13/2016; 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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