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

Catalog Number 398.651

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.No patient involvement.(b)(4).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No anomalies were detected during device history record review.No ncrs 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.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 by sterile processing that screw removal pliers were found broken into three pieces.There was no patient involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: one narrow screw removal pliers (part 398.651, lot 3475780) was returned for investigation.The device was returned and reported to have been found broken.This condition is confirmed; the leaf spring of the pliers has sheared off at the location where it is secured to the handle.The root cause of the complaint condition is unknown, but it is likely that consistent use over the life of the device and possibly rough handling during surgery or sterile processing have led to this complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint condition is confirmed.Per the technique guide, the narrow screw removal pliers are an instrument routinely used in the screw removal set.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The root cause of the complaint condition is unknown, but it is likely that consistent use over the life of the device and possibly rough handling during surgery or sterile processing have led to this complaint condition.The design is determined to be adequate for its intended use when used and maintained as recommended.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5880250
• MDR Text Key: 52280086
• Report Number: 3003862213-2016-10025
• Device Sequence Number: 1
• Product Code: HTC
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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: 3475780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2010
• 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