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

Catalog Number A3059

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 08/16/2023

Event Type  Injury  

Event Description

A facility reported that the mayfield composite series skull clamp (a3059) was very stiff and some wearing/rubbing when pulling the clamp apart was noted.The clamp was used on a a patient, and when moving the patient, a laceration to the head occurred.The patient required staples/sutures to the laceration.Surgical delay is unknown.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received indicating the following: 1.Please describe what part exactly is stiff and which part was moving or caused the laceration if possible.Answer: the two halves of the actual clamp were quite stiff, however i noticed when looking at the clamp the day after the incident (i wasn¿t present at the time of the incident) that the serial numbers for the 2 halves of the clamp didn¿t match.After finding the matching half and putting the clamp together there was no longer any stiffness.2.Which pin side caused the laceration (single/double?) answer: the staff involved were also unsure as to which part of the clamp caused the laceration, but seeing as there was only 1 laceration i feel it must be the side with only 1 pin? 3.Were mayfield pins used? answer: yes, we only stock mayfield pins.4.Moving of the patient ¿ please describe the positioning of the patient.Answer: prone, incident occurred while transferring from supine to prone position while in skull pins.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Additional information: 1.Was there a delay in surgery due to product problem? if yes, how long? yes unsure how long.2.Size and location of the laceration? right side of the skull, information on size not provided.3.Patient outcome? bleeding ceased once staples applied.Patient received staples/sutures to laceration.Investigation findings: the mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs team could not duplicate slippage, and no other fault/failure of the device was found.However, annual preventative maintenance is recommended.Root cause - probable root cause of patient laceration is improper or suboptimal positioning of the skull clamp.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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
• 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: 17704309
• MDR Text Key: 322924138
• Report Number: 3004608878-2023-00164
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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