MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA SPEED-TRACT STERILE FIELD POST WITH COUPLER; SURGICAL RETRACTOR

Catalog Number 11321

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

On 5/18/2016 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis: the customer¿s complaint noted above has been confirmed by engineering.During evaluation of the returned unit, engineering noticed that the field post would not fully clamp onto the test rail.As the field post was being clamped onto the test rail, resistance was felt in the knob of the bolt subassembly which subsequently caused the field post to seize up completely.The unit would seize up and halt any further rotational movement of the knob.There is a considerable amount of wear and tear present over the entire surface of the defective field post which is expected from regular usage over a significant period of time.Device history evaluation: device history record reviewed for this product id shows no abnormalities related to the reported failure.The device manufactured with this lot code passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.Conclusion: the presence of residual contaminates within the threads of the ¿bolt¿ and the mating ¿welded post subassembly, speed-tract¿ are the primary causes for the observed resistance.The presence of these foreign contaminates are obstructing the mating threads during engagement, and as a result prevents the end user from properly/fully clamping the field posts onto the bed rail as stated.It¿s likely the unit was not properly lubricated during post-cleaning inspections throughout its span of usage.The ifu instructs the end user to lubricate any ¿metal to metal¿ threading with a surgically acceptable lubricant in an effort to reduce frictional wear and tear of the components.

Event Description

Customer initially reports post will not tighten to rail.On (b)(6) 2016 no further information available.

• Brand Name: SPEED-TRACT STERILE FIELD POST WITH COUPLER
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5709257
• MDR Text Key: 46898492
• Report Number: 2523190-2016-00090
• Device Sequence Number: 1
• Product Code: FFO
• 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: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2013
• 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