MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD CABLE PMIO MPM-1; N/A

Catalog Number PMIOMPM1

Device Problems Break (1069); Material Fragmentation (1261); Material Separation (1562); Material Integrity Problem (2978)

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

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

The customer disposed the device and thus is not able to return it.

Event Description

On (b)(6) 2015, while trying to disconnect icp-60 cable from pmiompm1, the pmiompm1 connector was separated.The cable parts broke apart when a nurse tried to disconnect the cable.The event was discovered during preparation to move the patient, thus the product was not in contact with the patient; no patient injury or death alleged.There was no increase in surgery time.A photograph of the separation was provided.The customer disposed the device and thus is not able to return it.

Manufacturer Narrative

Integra has completed the internal investigation for this device complaint on (b)(6) 2016.The investigation included: review of device history records.Review of complaint history.The product was not returned for evaluation.The customer had disposed of the defective cable to replace it with a new cable since the defective cable was not repairable; a review of the device history records (dhr) review could not be completed for pmiompm1 cable since neither the serial nor the lot number were provided due to disposal of the actual device by the customer.The analysis of the complaint investigations and root cause reports has concluded there are two identified complaints for the reported failure associated with the pmiompm cable that has not been returned for evaluation.No trend has been identified.The product was not returned for evaluation; therefore, the specific cause for the problem reported could not be identified and no root cause can be determined.If additional information, such as lot or serial number, is obtained, the investigation will be reopened.

• Brand Name: CABLE PMIO MPM-1
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD; newbury road; newbury road; andover hampshire ; UK
• Manufacturer (Section G): INTEGRA NEUROSCIENCES, LTD; newbury road; andover hampshire ; UK
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5348137
• MDR Text Key: 35610299
• Report Number: 8010219-2015-00073
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMIOMPM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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