MAUDE Adverse Event Report: UMKIRCH NARROW SCREW REMOVAL PLIERS; PLIERS,SURGICAL

Catalog Number 398.651

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: patient id, age, dob & weight not provided for reporting.Subject device has been received and an a product evaluation was performed: customer quality (cq) investigation: two 398.651 narrow screw removal pliers with lot numbers 3328120 and 3304239 were returned and reported to not be locking properly during surgery.This complaint condition was likely caused by over seven years of consistent use and possible rough handling during surgery or sterile processing; 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.It is likely that over seven years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition this complaint is confirmed.Investigation methods/evaluation results: the 398.651 narrow screw removal pliers is an instrument routinely used in the screw removal set the devices was returned and reported to not be locking properly during surgery.This condition is confirmed; the leaf spring for both devices is broken causing the locking mechanism not to function properly.It is likely that over seven years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.Lot 3328120 was manufactured in 1/2010 and is seven years old.Lot 3304239 was manufactured in 12/2009 and is over seven years old.The balance of a 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 for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.Device history records review was conducted.Part# 398.651, lot# 3328120, manufacturing location: (b)(4), manufacturing date: 21.Jan.2010.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported during a tibia hardware removal on (b)(6) 2016, two narrow screw removal pliers would not function intraoperatively.The locking mechanism appears to be non-functional in both instruments.The pliers were from two different screw removal sets.The hardware removal was planned with no allegation or serious injury against the implanted devices.The surgeon used an alternate instrument in one of the sets, to remove the screws and hardware.No surgical delay was reported.The procedure was completed successfully and all hardware was removed intact with no devices left behind in the patient.This complaint involves 2 devices.Concomitant devices: screw (part/lot # unknown, qty unknown).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: based off of investigation, device code added/included in the complaint.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: NARROW SCREW REMOVAL PLIERS
• Type of Device: PLIERS,SURGICAL
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6325851
• MDR Text Key: 67329034
• Report Number: 3003862213-2017-10005
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982201508
• UDI-Public: (01)10886982201508(10)3328120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 398.651
• Device Lot Number: 3328120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2010
• 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
• Treatment: SCREW (PART/LOT # UNKNOWN, QTY UNKNOWN)