MAUDE Adverse Event Report: UMKIRCH APPLICATION INSTR W/ALIGNMENT GUIDE FOR CRANIAL TUBE CLAMP; CRIMPER, PIN

Catalog Number 329.323

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing site: (b)(4)- manufacturing date: january 27, 2009.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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 (b)(4) reports an event as follows: it was reported that a patient underwent a cranioplasty on (b)(6) 2016.During the procedure, the application instrument for the cranial tube clamp did not seat the clamps as expected.An additional instrument tray was available and opened.The same instrument from the new set was used to successfully complete the procedure.A minor delay of an unspecified amount of time was noted.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device 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.

Manufacturer Narrative

Product investigation summary: the application instrument (part: 329.323 / lot: 3076204) was returned with a report that it would not be seat the clamps as it should.The complaint condition was likely caused by dullness and wear from over seven years of consistent use; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, functional test and drawing review were performed as part of this investigation.The application instrument is routinely used in the cranial clamps with application instrument system.The crimping and cutting edges of the returned device show some wear and dullness that could possibly preclude proper clamp fixation.The device was manufactured in january, 2009 and is over seven years old.The balance of the returned device is in otherwise good condition, although the spring mechanism does run somewhat roughly.The relevant drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable.Upon review of the device history record, no non-conformances were noted during the production of this device.Device 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: APPLICATION INSTR W/ALIGNMENT GUIDE FOR CRANIAL TUBE CLAMP
• Type of Device: CRIMPER, PIN
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5706039
• MDR Text Key: 48250895
• Report Number: 3003862213-2016-10018
• Device Sequence Number: 1
• Product Code: HXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.323
• Device Lot Number: 3076204
• Other Device ID Number: (01)10887587039299(10)3076204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2009
• 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