MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Break (1069)

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.Linked to mfr report number 3004608878-2019-00162, 3004608878-2019-00164.

Event Description

This is 2 of 3 reports.An account manager reported on behalf of the customer that on an unspecified date, an a1059 mayfield modified skull clamp was sent in for repair due to a broken lock.This was discovered during the weekly inspection of devices.There was no patient prepped for surgery and there was no surgery delay.

Manufacturer Narrative

The unit was received with the lock having both rotational and lateral movement and a residue buildup was present.Upon disassembly, it was noted that the lock would need new components added to replace worn internal parts.The unit needed to be machined to have heli-coils added to large starburst threads; the set screw in the swivel base was tight;.General maintenance and cleaning required.The device history record showed no abnormalities related to the reported incident nor were there any variances, mrr¿s or reworks associated with this lot/work order number.There was no service history on file.The reported complaint was confirmed.Root cause of the movement was most likely due to wear and tear, however, the observed residue build up was most likely the result of decontamination or sterilization method outside the prescribed and validated method in the instructions for use (ifu).

Event Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8771258
• MDR Text Key: 150831602
• Report Number: 3004608878-2019-00163
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1