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 Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.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.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

It was reported that during a routine field equipment inspection of a modular clavicle set, it was discovered that the screw was missing on the bottom of the pliers.There was no procedure or patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records was conducted.The report indicates that the: manufacturing date: jan 29th, 2010 part#: 329.291, lot#: t943130, review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.The photo and the complaint description show that the screw is missing but the threads were checked at the final inspection of the device on 29th january 2010 and found to be conforming.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

Product investigation summary: the complaint condition for the bending pliers (part 329.291 / lot t943130) was likely caused by the tightening screw being lost upon disassembly in sterile processing; however, this complaint is not likely a result of any design related deficiency.The bending pliers are an instrument routinely used in the 3.5mm lcp superior anterior clavicle plates system.The device was returned and reported to have been found without the screw in the bottom handle of the pliers.This condition is confirmed as the tightening screw was not returned with the device.It is likely that the screw was lost upon disassembly during sterile processing leading to this complaint condition.The device was manufactured in january, 2010 and is six (6) years old.The balance of the returned device is in fair working condition consistent with six (6) years of use.The associated drawing number 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.No non-conformance reports were generated during the production of this device.The complainant part was actually received by the manufacturer for evaluation on december 18, 2015.Field updated with new date of receipt.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: 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: 5315362
• MDR Text Key: 34018202
• Report Number: 9680938-2015-10130
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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: T943130
• Other Device ID Number: (01)10886982191946(10)T943130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2010
• 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