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

Catalog Number A3059

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Event Description

This is the first of two complaints (same incident, different product ids).Linked to mfg.Report numbers: 3004608878-2017-00194.It was initially reported that the device was being sent to integra for repair.Additional information was received on 14jun2017, with the following: the thread of a3059 and a3018 was damaged on their own.The issue was discovered during surgery, were it was noticed that the threads were damaged for a3059 and a3018.The patient was asleep when the issue was discovered.The event lead to an increase of surgery time of 15 minutes for repositioning the patient.The patient had three additional mayfield skull pin marks.Patient's age and gender is unknown.They finished the surgery by changing the equipment during the surgery.No other information was provided.

Manufacturer Narrative

Integra has completed their internal investigation on july 5, 2017.Results: evaluation of returned device: evaluation verified customer information as valid.The teeth and the threads of the base are severely damaged.Small parts are worn out.Dhr review: a total of 35 were manufactured on 12/29/2016 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mfr¿s, variances or rework.Complaints history: a two year lookback from 06/18/2015 to 06/18/2017 for this reported failure using key words ""threads "" for product id (b)(4) shows that 3 complaints were received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: complaint was confirmed for damaged threads.From the failure analysis it appears that the device was damaged by the user - possible cross threading which ruined the threads.During the failure analysis it was decided to also rebuild the locking mechanism due to normal wear and tear.

• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6663074
• MDR Text Key: 78276124
• Report Number: 3004608878-2017-00193
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• 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: 06/07/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other