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

Catalog Number A3059

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the screw and spring came out of the single pin side of the skull clamp as they were trying to torque it down on the patient.There was a 15 minute delay in surgery.The patient was prepped for surgery.There was no patient injury.Additional information was requested and on (b)(6) 2015, the following was provided by the customer: the customer did not have any information on the patient that this skull clamp was used on prior to this occurrence.The skull clamp was returned from the cleaning process in the 3 pieces.The portion of the skull clamp with the single pin holder was in 3 pieces: frame with knob, spring and inner medal tube.This did not impact any patient directly since it occurred after the case while being cleaned.There are no pins available for evaluation due to they are disposable and were discarded after the case and prior to the mayfield set being sent to the denomination area.Integra adult disposable skull pins are used at our facility.The skull clamp was immediately removed form service.

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: 5050566
• MDR Text Key: 25510694
• Report Number: 3004608878-2015-00237
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2015
• 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