MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS

Catalog Number A2101

Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)

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

Event Date 04/06/2017

Event Type  malfunction  

Event Description

An (b)(6) male patient was prepped for neurosurgery for a chiari malformation.It was reported that the patient's head slipped.The head was caught by the attending nurse.There were no scratches or lacerations reported.No medical intervention required.There was an approximate 10 minute delay in surgery while the device was swapped out.The surgery was completed with another base unit.

Manufacturer Narrative

Integra has completed their internal investigation on may 16, 2017.Results: evaluation of returned device; base unit has been cleaned and inspected.Shock cushion has hardened and discolored with age resulting in increased force applied to mating parts, as well as impinging on cam rod movement.Recommend unit undergo general servicing replacing minor components as per this estimate.This will restore full function of the unit to manufacturers¿ specifications.Swivel base has non oem retaining rings, and is displaying early signs of wear.Recommend replacing minor wearing parts as per this estimate.Dhr review; no abnormalities related to the reported failure.Complaints history; a two year lookback in trackwise for this reported failure and or related to "head slipped " for product id a2101 shows that 8 complaints were received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: root cause was worn parts.Shock cushion has hardened and discolored with age resulting in increased force applied to mating parts, as well as impinging on cam rod movement.

• Brand Name: MAYFIELD ULTRA BASE UNIT
• Type of Device: BASE UNITS AND ADAPTERS
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6507660
• MDR Text Key: 73503118
• Report Number: 3004608878-2017-00113
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2101
• Device Lot Number: 127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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
• Patient Age: 18 YR