MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD DISPOSABLE CHILD SKULL PIN (STEEL); N/A

Model Number A1084

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 2 reports linked to mfg report number 3004608878-2022-00253: a facility reported that one of the surgeons was about to use pediatric pins on an adult patient, but fortunately realized prior to the case and the pins were changed.Nurse manager believes that the main reason was that the packaging for a1083 mayfield adult pins and a1084 mayfield pediatric pins looks similar in size and the pin protectors are both blue.There was no patient contact and no delay in surgery reported.

Manufacturer Narrative

Mayfield disposable child skull pin (a1084) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.However, this issue was internally investigated, and determined to be customer error and not a product deficiency.The internal review found there were only two complaints from the same facility for this issue, and there has been no other recent complaints reported for pediatric skull pins or an issue differentiating between adult and pediatric disposable skull pins.The current package labeling for the a1084 pediatric skull pins meets all requirements and is properly labeled to identify the product.Additionally, there is not a negative trend with complaint data that would trigger an action.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Corrected field: h6 (medical device problem code 1).This mdr is being submitted for correction of an error which was submitted in the initial mdr."medical device problem code" should have been coded as 4052 (see below).

• Brand Name: MAYFIELD DISPOSABLE CHILD SKULL PIN (STEEL)
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15924241
• MDR Text Key: 305918013
• Report Number: 3004608878-2022-00254
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780025795
• UDI-Public: 10381780025795
• Combination Product (y/n): N
• PMA/PMN Number: K941558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1084
• Device Catalogue Number: A1084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2023
• 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