MAUDE Adverse Event Report: SYNTHES TUTTLINGEN IN SITU BENDER-RIGHT; INSTR., BENDING OR CONTOURING

Catalog Number 388.112

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/23/2014

Event Type  malfunction  

Event Description

It was reported that during surgery utilizing the in-situ benders, the bender tips splayed open.The surgery included 5.5 mm rods in a deformity construct in levels t6-s2.The case resumed with the construct complete, and without delay or complications for the patient.There were no fragments and the patient outcome was good.The damaged tips were first noticed postoperatively, during cleaning of the instruments.This report is for the right side bender this is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device name: hxw.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history records has been requested.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

Device was used for treatment, not diagnosis.The device history record review could not be performed as the records could not be identified as device is over 9 years old.The visual inspection of the returned device performed as part of the product investigation reported the part was received with the slot opening at the curved end bent open.Material deformation is evident at both openings.One in situ rod bender right (part# 388.112 lot# a7qa28) and one in situ rod bender left (part# 388.113 lot# a7qa28) were returned for the tips reportedly bending open.The benders are included in uss, pangea, and click¿x systems for in situ sagittal plane bending of rods.Alternatively, rod benders 388.91, 388.92, 388.112, 388.113, 388.117, 388.961, 03.620.020, 03.622.060, 03.622.061, and 03.622.062 may be used to achieve contouring of the rods (technique guides: j4437-b, j7243-b, j6418-c, j5462-b, j9009-b, j6718-a).Product drawings 388_112 rev c and 388_113 were reviewed during the investigation.Both instruments have the slot opening, where the instrument is placed around the rod, bent open.The openings have yielded material along the lateral half suggesting that the instrument may not have been fully seated around the rod when used.Multiple areas of material deformation at the opening also indicate that excessive force may have been used repeatedly.Both benders are made from h900 heat treated 17-4ph and is appropriate for the intended use of the instruments as h900 provides maximum hardness.Wear coupled with user technique may have caused the complaint condition however the user technique is unknown and so the root cause is indeterminate.Review of the product drawings found the material, dimensions, tolerances and finishing process of the instruments adequate for their intended use.The complaint may be a result of gradual wear, applying excessive bending force or user technique although it cannot be definitively determined which contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IN SITU BENDER-RIGHT
• Type of Device: INSTR., BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen PA 19380 785; GM 19380 7853
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4013052
• MDR Text Key: 4878567
• Report Number: 2520274-2014-13168
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.112
• Device Lot Number: A7QA28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2005
• 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