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

Catalog Number A3059

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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 surgeons were having difficulty in turning the knob of the a3059 mayfield composite series skull clamp to lock position when in use with the patient while pressure was applied.The incident occurred early in (b)(6) 2020 during a microvascular decompression (mvd).It was also reported that the incident caused a minor laceration around 1.5cm.There was an unspecified delay in surgery as the surgeon needed to apply manual pressure to the wound to stop the bleeding.They further tighten the knob after the problem occurred.The patient's post procedure condition was reported as stable.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The device history record showed no abnormalities related to the reported failure.The returned unit did not meet all specific functional test.The evaluation showed that there was difficulty locking the swivel lock knob when the clamp pressure is more that 20 ibs.The observed condition is likely caused by wear and tear/ improper handling of the device.The definite root cause cannot be reliably determined.The reported complaint was confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

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 45227
• MDR Report Key: 10261234
• MDR Text Key: 198518526
• Report Number: 3004608878-2020-00359
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 08/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1