MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI CRANIAL FLAP TUBE CLAMP 18MM DIA-STERILE; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number 460.002.01S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4).Device broke intra-operatively and was not fully implanted or explanted.The review of the device history record for part 460.002.01s and lot 8095927 revealed that no non conformance reports (ncrs) were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the procedure performed on (b)(6) 2016 it was noticed that the shaft of the titanium cranial flap tube clamp was broken.The broken piece was retrieved.New implant was readily available to complete the procedure.Surgery was completed with no patient harm or surgical delay.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device (ti cranial flap tube clamp, part number 460.002.01s, lot number 8095927).Only the top disk 18mm and the bottom disk 18mm were received for investigation.The tube is broken off at the connection to the top disk.The preformed top disk is slightly deformed.The bottom disk shows marks of a forceps and a portion of the tube was blocked in the center hole.Also the bottom disk was deformed during an unknown procedure.Because of the missing component and the existing damage all complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.The dhr review shows that the devices met the specifications at the time of manufacturing and distributing.Lot 8095927 was manufactured in october 2012, 70 parts according to our specifications.All devices were sold meanwhile and we are not aware of any quality issues associated with this article- and lot number.A final manufacturing conclusion cannot be presented because of the condition of the product and the poor clinical information received.We determine that the most probable root cause is excessive force through the method of use and associated accumulated damage and wear.No manufacturing related issue was identified and/or confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI CRANIAL FLAP TUBE CLAMP 18MM DIA-STERILE
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6011936
• MDR Text Key: 56967207
• Report Number: 1000562954-2016-10191
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 460.002.01S
• Device Lot Number: 8095927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1