MAUDE Adverse Event Report: UMKIRCH CABLE CUTTER; CUTTER, WIRE

Catalog Number 03.607.513

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during cutting; the tip of the cutting area on the front cutter broke off.There was no delay to surgery time and no reported patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and a device history review was performed.The investigation of the complaint articles indicates that the:03.607.513 lot, 8715546, manufacturing location: (b)(4), manufacturing date: 04.Dec.2013, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Update 11.November 2015: issue happened out of the operating area.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional information: a product development evaluation was performed for the subject device (cable cutter, part number 03.607.513, lot number 8715546).The subject device was received clean and with the instrument tip broken.Subcomponent (b)(4) is missing a small fragment.The instrument was reported as damaged out of the operative environment and did not involve any patient in the issue faced by user.The part of the pliers that broke out is not supposed to experience any load.This damage can only be obtained by pinching an object between the guiding block and its counterpart.The load of a normal usage goes through the cutting edge and not through the guiding block.Although the complaint condition was confirmed, a root cause cannot be definitively determined.Product fault could not be detected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CABLE CUTTER
• Type of Device: CUTTER, WIRE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5197638
• MDR Text Key: 30258732
• Report Number: 3003862213-2015-10037
• Device Sequence Number: 1
• Product Code: HXZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2015

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: 03.607.513
• Device Lot Number: 8715546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2015; 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• 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