MAUDE Adverse Event Report: SYNTHES TUTTLINGEN BENDING PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH; INSTR, BENDING OR CONTOURING

Catalog Number 329.291

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a pair of bending pliers no longer worked properly as they would not bend plates as they should.The issue was reportedly discovered during an inspection prior to a surgical procedure.The patient had not been brought into the operating room at the time; therefore, no patient involvement is assessed for this event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history review: manufacturing date: october 28, 2009 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.The raw materials, which were delivered as lots 70381, 839003, kr327639, and kr82671, are corresponding to the specifications.The hardness was measured at the time of the manufacturing between 47.8-48.0 hrc and was found to be good.No non-conformance reports were generated during production.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

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.

Manufacturer Narrative

Additional narrative: a product evaluation was performed.The investigation of the complaint articles indicates that: the 329.291 bending pliers are an instrument routinely used in the 3.5mm lcp superior anterior clavicle plates system ((b)(4)).The device was returned and reported to no longer be working properly.This condition is confirmed; the ball bearing in the central lever has corroded to the point at which the stop lever will advance farther down the lever than designed.It is likely that five years of use and sterilization cycles has led to the wear which has led to this complaint condition.The device was manufactured in 10/2009 and is over five years old.The balance of the returned device is in fairly worn condition.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 and is not likely a result of any design related deficiency.Whether the complaint condition for this device can be replicated is not applicable for this 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.

• Brand Name: BENDING PLIERS FOR 3.5MM CLAVICLE PLATES/227MM LENGTH
• Type of Device: INSTR, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4918725
• MDR Text Key: 6010063
• Report Number: 9680938-2015-10063
• Device Sequence Number: 1
• Product Code: HXP
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.291
• Device Lot Number: T940955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2009
• 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