MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM; STEREOTAXY

Catalog Number CRWPRECISE

Device Problems Entrapment of Device (1212); Imprecision (1307); Loose or Intermittent Connection (1371); Sticking (1597); Component Missing (2306); Device Operates Differently Than Expected (2913)

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

Event Date 06/02/2016

Event Type  malfunction  

Event Description

A report was received for the crwprecise crw precision arc system.It stated that the one of the two precision arcs failed in use during deep brain stimulation (dbs) surgery on (b)(6) 2016.It worked acceptably [ok] for one target setting, although it has been noted to have apparently been hard to turn in the last several cases.For the second target, the trunnion ring could not be turned outside a short range and it could not be locked in place.The arc was replaced with the second, newer precision arc.An inspection of the first arc revealed a missing screw.Since the loose screw could not be found, it seems likely that the screw gradually went deeper into its hole and finally lodged in a place where it interferes with rotation of the ring.The patient, a male of (b)(6), was not injured as a result of the product problem, however, there was a delay in the surgery by 20 minutes.

Manufacturer Narrative

Integra has completed their internal investigation on 29 jul 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the reported complaint was confirmed.A visual inspection of the returned unit found a broken pin on the right of trunion support base thumb screw.Residue was found inside of both trunion supports.The full dog set screw was found to have been accidentally over tightened, locking the twist handle causing the frozen condition.Lack of lubricant causing unit is having problem with operation.Note that the crwprecise returned without a case and no accessories.It was also, noted that this unit has not been in for service since feb 2013.User error - lack of proper cleaning and maintenance.Device history record reviewed for this product id - manufactured: november 30, 2012 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.A two year look back in trackwise for this reported failure and or related to "failed in use during dbs surgery" for this product id shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: the root cause is considered to be physical damage along with improper cleaning and maintenance of the device.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: CRW PRECISION ARC SYSTEM
• Type of Device: STEREOTAXY
• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5743253
• MDR Text Key: 48834180
• Report Number: 3004608878-2016-00161
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPRECISE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2012
• 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