MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1114

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

The locking mechanism for the 2 pin rocker arm was very loose.It could be easy locked and unlocked.Additional information was requested and on 16aug2016, the following was provided: the incident happened in the hospital and there was no casualties reported.No other information was provided.

Manufacturer Narrative

Integra has completed their internal investigation on 09/14/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation verified customer information as valid.Unit was delivered without adult rocker assembly.Locking mechanism is loosening.Device history record reviewed for this product id work order/lot code and serial # (b)(4) manufactured on november 04, 2014 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 lookback in (b)(6) for this reported failure and or related to "loose mechanism" for this product id shows that 4 complaints were received including this case, see below.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: the socket head cap screw was not enough tightened, this led that the locking mechanism went loosen.Root cause could be normal wear and tear.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 5901526
• MDR Text Key: 54044713
• Report Number: 3004608878-2016-00230
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114
• Device Lot Number: 009722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• 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