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

Catalog Number A3059

Device Problems Material Too Rigid or Stiff (1544); Sticking (1597)

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

Event Type  malfunction  

Event Description

It was reported that the mayfield skull clamp (a3059) has locked tight on to the swivel adaptor as it was being tightened together.This lead it to be completely stuck and the clamp having to be unscrewed off the patient's head.There was no patient injury or death alleged.The event lead to a 20-minute increase in surgery time.Additional information has been requested.

Manufacturer Narrative

Additional information received on 11jul2017: "there were no further consequences apart from the additional time to undo the clamp and place another clamp." integra has completed their internal investigation on august 1, 2017.Results: evaluation of returned device; during investigation the following was observed: evaluation verified customer information as valid.Thread of the starburst is damaged by the damaged stud headrest.Dhr review; 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.Complaints history; a two year look back from 07/10/2015 to 07/10/2017 for this reported failure using key words "stuck" and "thread" for product id a3059 shows that 1 complaint was received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: failure was confirmed in the failure analysis.Thread damage likely occurred due to cross threading and/or handling damage to thread stud.This caused distortion of threads upon screwing the two units together.

• 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: 6700481
• MDR Text Key: 79934603
• Report Number: 3004608878-2017-00209
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Device Lot Number: SS150826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2017
• 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