MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PHANTOM BASE ASSEMBLY; N/A

Catalog Number CRWPBS

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg.Report number 3004608878-2019-00070.

Event Description

This is 2 of 2 reports.The sales representative reported on behalf of the customer that the loaners crw precise (crw precision arc system) and crw pbs (phantom base assembly) were used for surgery on (b)(6) 2019.When the coordinates were entered, it was noticed that the correct target was not achieved.After frequent checking of the settings and coordinates, the correct target was still not achieved.After surgery, the crw precise and crw pbs were put on zero (0).A deviation of almost 1 mm was noted.The conclusion was that the crw precise and crw pbs did not have the correct calibration conditions.Complementary information was received on 03/22/2019 and 04/01/2019 indicating that the they did not reach the exact point that they planned because of the uncalibrated crw precise and crw pbs.At the moment, the stimulation for the patient works using a low electric current for stimulation; in the future the current will increase so they hope the patient will not have side effects with a higher current because the sensor is not at the exact spot.Surgery took 30 minutes longer because of the incorrect calibration.

Manufacturer Narrative

The device was received for evaluation with the nylon tips of the thumb screws damaged and both the spring plungers worn out.All these have to be replaced.The pointed rod and the locator point were missing and had to be added.The baseline measurements could not be performed during the evaluation due to the damaged nylon tips to verify the customer information as valid.The unit also had to be calibrated.Device history record reviewed showed no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.The complaint was confirmed.The underlying root cause for the reported event was the pointed rod and the locater pointer were missing and the nylon tips of the thumb screw were damaged.

Event Description

N/a.

• Brand Name: PHANTOM BASE ASSEMBLY
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8496107
• MDR Text Key: 150857145
• Report Number: 3004608878-2019-00071
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWPBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1