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

Catalog Number A1059

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

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

Event Type  malfunction  

Event Description

The customer was claiming the torque screw was loose and could not close/fix.Engineers from the distributor confirmed the torque screw did not work (could not close/fix).The unit failed after one month of use additional information received from the distributor on 17apr2017 : the new device could not be used at all because of faulty screws (fixing the skull).The other clamp was used instead.All other questions asked related to patient impact and surgery details were not provided by the distributor (answered: n/a).

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: during investigation the following was observed: evaluation verified customer information as valid.The swivel base became loose and in regards of this the locking mechanism felt apart.No failure found at the torque screw.Device is first time in service.Device history record reviewed for lot/ 169 -sn (b)(4) on job# (b)(4) where 30 pcs were manufactured on (b)(6) 2016.Thirty pieces were made, the dhr on both the assembly and subassembly level show 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.No service history is on file for this device.Sampling plan is 100% a two year lookback in trackwise from (b)(6) 2015 to (b)(6) 2017 for this reported failure using key words "starburst teeth worn and worn teeth " for product id (b)(6) shows that 10 complaints were received including this case, see below.It should be noted that 9 were reported by the same customer/ distributor.Conclusion: the root cause per integra service team's findings, is the swivel base was worn and damaged along some small assembly mating parts.This condition before repair caused the unit to have excess movement and feel very loose.

• Brand Name: MAYFIELD MODIFIED 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: 6555515
• MDR Text Key: 74907218
• Report Number: 3004608878-2017-00148
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• 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: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 201658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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