MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP

Catalog Number A3059

Device Problems Disassembly (1168); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It was reported that the torque bolt pin came loose during cleaning in the sterile processing department (spd).It was not used on a patient.

Manufacturer Narrative

Integra completed their internal investigation on (b)(6) 2015: methods: evaluation of actual device.Device history record review.Complaint history review.Results: engineering and repairs were able to verify the customer complaint.The device history record for the unit(s) listed in this complaint under lot code/work order: (b)(4) on (b)(6) 2015.A total of (b)(4) were produced of this lot.No abnormalities relate to reported incident found nor where there any variances, mrr¿s or reworks associated with this lot/work order number.No service history on file.Conclusion: engineering and repairs were able to verify the customer complaint.The root cause cannot be 100% attributed at this time.Capa was opened for the torque screws unintentionally disassembling with the purpose to find the root cause and action items to address it.This issue will be monitored for trending.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: COMPOSITE SERIES
• 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: 5061866
• MDR Text Key: 25829934
• Report Number: 3004608878-2015-00240
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K120633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2015
• 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