MAUDE Adverse Event Report: JARIT 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 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

On 5/24/2017 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - one rhoto hook returned in used condition, showing minimal wear and a broken tip.Without knowing how much pressure was used to the tip when in use, the cause is undetermined.This type of damage is usually the result from improper usage.The complaint report is confirmed; damaged/worn.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Health hazard engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none.Evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

Event Description

Customer initially reports that doctor was performing a adcf using the rhoton hook and felt the tip break off.He searched the patient cavity to find the broken piece and could not find it.He thinks it may have been sucked up by the suction they were using but isn't positive.The rest of the case was completed without additional incidence.On (b)(6) 2017 doctor was performing a cervical 3-7 anterior cervical discectomy fusion.X-ray was taken.No harm done.

• Brand Name: RHOTON-TYPE HOOK 71/2 90D BLT
• Type of Device: N/A
• Manufacturer (Section D): JARIT; j. jamner surg inst inc.; j. jamner surg inst inc.; hawthorne NY 10532
• Manufacturer (Section G): JARIT; j. jamner surg inst inc.; 9 skyline drive; hawthorne NY 10532
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6601188
• MDR Text Key: 76501558
• Report Number: 2523190-2017-00059
• 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
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 277269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 48 YR