MAUDE Adverse Event Report: INTEGRA YORK, PA. INC. DETACH CRVL RONG TF 3MM 8 40

Catalog Number 281061DT

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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

Event Date 06/25/2015

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 it is the third time screw has come out during the procedure and surgeon is very upset.On (b)(6) 2015 customer reports doctor was performing a posterior cervical laminectomy.No further information available.

Manufacturer Narrative

On 9/23/15 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - there were 2 cervical rongeurs returned, the first one (3371) showing wear with green/yellow tape markings and the second one (3360) showing wear, purple tape marking missing screw.Not knowing how the rongeurs were handled/maintained during use and while in autoclave, the damage to the instrument is not identified as a workmanship or material deficiency.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: there is no applicable variance authorization / deviation history.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: the complaint is confirmed, root cause undetermined.

• Brand Name: DETACH CRVL RONG TF 3MM 8 40
• 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 ; 6099362393
• MDR Report Key: 5004162
• MDR Text Key: 24067001
• Report Number: 2523190-2015-00050
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 281061DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR