MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC); N/A

Catalog Number A1072

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Correction: this a correction mdr for initial mdr mfg report#: 2023988-2016-00018 was submitted under incorrect integra lifesciences (b)(4) on 06/14/2016.Integra has completed their internal investigation on 26 jul 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: engineering and quality were able to confirm the customer complaint.During the inspection, there were two skull pins that had some type of foreign material stuck on their surfaces, and there was one skull pin with a piece of hair found inside the sterilized pouch.Device history record reviewed for this product id lot #: 1160076 manufactured on match 03, 2016 show no abnormalities related to the reported failure.A total of (b)(4) pouches ((b)(4)) were manufactured and all passed required inspection points with no associated mrr¿s, variances or rework.No service history is on file for the returned items.A two year lookback in (b)(6) for this reported failure and or related to "contamination" for this product family shows that no additional complaints were received.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: engineering and quality were able to verify the customer complaints.The root cause to the hair strand found inside the sterilized pouch may have occurred during the sterilization process.The skull pins with the contaminants/foreign material on their surfaces cannot be 100% attributed at this time as there is no certainty as to what stage of the manufacturing process (from assembly to sterilization) this may have occurred.Furthermore, these two skull pins were sent out to get analyzed at a lab.This is an isolated incident and will be monitored for trending.

Event Description

This is the first of two reports (same product id, similar product problem, same lot number and same distributor).Linked to mfg report: 3004608878-2016-00210.During the inspection of incoming goods the distributor found that the a1072 mayfield disposable adult skull pins had a contamination adhered to them.There was no patient contact or injury.No other information was provided.

• Brand Name: MAYFIELD DISPOSABLE ADULT SKULL PINS (PLASTIC)
• Type of Device: N/A
• 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: 5847859
• MDR Text Key: 51277237
• Report Number: 3004608878-2016-00209
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K923789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A1072
• Device Lot Number: 1160076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1