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 No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the lock of the a3059 mayfield composite series skull clamp would only turn 3/4 of the way to the lock symbol.This was observed when the surgeon went to use it.The incident date was unknown.After multiple attempts, it made a popping noise and the knob moved to the lock position.There was no patient involvement or delay in surgery.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h4, h6, h10.Udi # (b)(4).The device was returned for evaluation.The device history record (dhr) showed no abnormalities related to the reported failure.The functional testing showed that the returned unit it has passed all specific functional testing requirements.No issues was observed, therefore, the reported complaint was not confirmed from the evaluation.

• 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
• MDR Report Key: 10280823
• MDR Text Key: 203358269
• Report Number: 3004608878-2020-00303
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1