MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRI-STAR SWIVEL ADAPTOR; SKULL PINS

Catalog Number A2008

Device Problem Bent (1059)

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

Event Date 11/27/2015

Event Type  malfunction  

Event Description

The torque screw was bent.It was also hard to mount the adaptor to the a2101 base unit.The product problem was discovered during setup, before the procedure.There was no patient contact.The patient was not anesthetized when the issue occurred.Patient age, gender, type of surgery were unknown.A replacement product was available to be used.There was no surgery delay.

Manufacturer Narrative

Integra has completed their internal investigation on 2/9/2016.The investigation included: methods: evaluation of actual device; review of device history records; review of complaint history.Results: evaluation of device: the torque screw of a2008 was bent.Device history record reviewed for this product id lot code154 and serial# (b)(4) manufactured on 04/18/2015 (qty (b)(4)) show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file.No new design or manufacturing trends have been identified.In summary, the end users reason for return was verified.The most likely cause could not be determined.

• Brand Name: MAYFIELD TRI-STAR SWIVEL ADAPTOR
• Type of Device: SKULL PINS
• 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: 5310151
• MDR Text Key: 34741087
• Report Number: 3004608878-2015-00309
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2008
• Device Lot Number: 154/12465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2015
• 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