MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-BITE STERNAL NH 7-3/4

Catalog Number 121260

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2015

Event Type  malfunction  

Event Description

Customer (b)(4) - event desc: surgeon using bulldog jarit 121-260 carb-bite to remove abx spacer when a piece of the tip broke off.Majority was removed, x-ray taken and no object noted.On (b)(6) 2015 customer reports that "the patient had a removal of antibiotic spacer, sequestrectomy of osteomyelitis, and intramedullary nailfixation of her right femur.The surgeon was using a type of needle holder, called a "bulldog" needle holder (jarit 121-260) to try to explant a spacer which had gotten caught in bone, while in use.In the process of pulling this metal piece out, the tip of the needle holder broke.They were able to locate the larger of the two fragments of needle holder, but not the smaller.A flate plate x-ray was taken and examined by both the surgeon and the radiologist and no retained surgical items were noted in the wound.The smaller piece of the needle holder was not visible on the film and was most likely was washed away by copious irrigation and suctioning of the wound.".

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.

Manufacturer Narrative

On 8/18/15 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the product was not returned for review.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: none.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.Product has not been returned for evaluation.

• Brand Name: CARB-BITE STERNAL NH 7-3/4
• Type of Device: NA
• 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; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4924646
• MDR Text Key: 6051243
• Report Number: 2523190-2015-00038
• Device Sequence Number: 1
• Product Code: GDF
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• 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
• Patient Age: 51 YR