MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD INFINITY SKULL CLAMP; N/A

Catalog Number A1114A

Device Problems Difficult to Remove (1528); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017, it was reported that the standard infinity skull clamp got stuck on the patient¿s head and had to be pried apart.Request for additional information was sent and on (b)(6) 2017, the following was provided by the customer: a (b)(6) -year-old female was undergoing an unknown procedure.It is unknown if the surgery was performed with a stereotaxy device.The action that was taken after the product problem occurred with the clamp was reported as ¿crawled under table and pried apart¿.Adult skull pins were used; the brand and lot number of skull pins were unknown.There was no patient injury or death alleged, and no revision/medical intervention was required.No delay in surgery due to product problem was reported.Patient outcome was ¿fine¿.The skull pins are not available to be returned for evaluation.

Manufacturer Narrative

Integra has completed their internal investigation on 11/20/2017.Device history record reviewed for work order /(b)(4) lot/ 097 manufactured on 9/14/2009 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points.*note this product was not a serialized item back in 2009; also this product was more than eight years old which is beyond our 7yr warranty period.A two year lookback from 10/10/2015 to 10/10/2017 for this reported failure using the key words " stuck" for product id a1114a shows that no additional complaints were received.No new design or manufacturing trends have been identified.The returned unit did not meet all specific functional test.Unit received with the lock sticking when unit is unlocked and rotated.The lock will need new components added to replace worn internal parts; unit requires pm maintenance at this time.Root cause analysis was worn components.

• Brand Name: STANDARD INFINITY SKULL CLAMP
• Type of Device: N/A
• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6945548
• MDR Text Key: 90444507
• Report Number: 3004608878-2017-00293
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2009
• 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: 54 YR