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

Catalog Number A3059

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

This is the first of two reports (same product id, same problem, same facility and same doctor).This report is in regards to the first device.Linked to mfr report: 3004608878-2016-00301.The surgeons were worried about how much movement the torque knob has on the a3059 mayfield composite series skull clamp.They are worried it will migrate or slip.The devices were not in contact with a patient and there was no patient injury reported.

Manufacturer Narrative

Integra completed its internal investigation 11/10/2016.The investigation included: method: dhr review.Review of complaint management database for similar complaints.Visual examination.Results: device history record reviewed for this product id under lot code/work order (b)(4) manufactured on 09/30/2016 show no abnormalities related to reported incident found.This device passed all required inspection points with no associated mrr¿s, variances or rework.No previous service history is on file.A two year look back for this reported failure and/or related to "too much movement¿ for this product id shows that 7 complaints were received including this case.It should be noted that these 7 complaints were reported by 4 customers.No new design or manufacturing trends have been identified.Engineering and quality were able to partially confirm the customer complaint.The part was inspected 100% functionally and it passed all its requirements.However, one of the skull clamps, (b)(4), experienced some wobbling inside the ratchet extension.The returned device was connected to the test monitor and the display read 99/888/15, which is indicative of a broken optical fiber.Visual inspection revealed a bend at the proximal end of the plastic white sleeve.Conclusion: the root cause can be attributed to a processing issue.The ratchet arm extension, (b)(4), is casted and machined at a supplier where they inspect 100% through the whole lot prior to sending it to integra.

• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6090874
• MDR Text Key: 60024797
• Report Number: 3004608878-2016-00300
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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: 10/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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