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

Catalog Number 388.112

Device Problem Break (1069)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that during an initial t2-l1 posterior fusion surgery the in-situ rod bender-right broke.It was reported the patient had scoliosis and had hard bones.After placing the rod and loading all the caps, the surgeon began using the rod bender, he bent the rod in a couple of areas but the bender snapped on the last area that he wanted to bend.A single broken shard was generated that was successfully retrieved from the patient and placed alongside the instrument at the back table.The surgery continued and the surgeon was happy with how the rod looked despite the broken instrument.There was no harm to the patient and surgery was delayed by two to three minutes.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information reported.Additional product code: hwx.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material which was delivered as lot #00057650 is corresponding to the specifications.The hardness was measured at the time of the manufacturing at 46,9 hrc and was found to be good.No ncrs were generated during production.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A product investigation was completed: one in situ rod bender (388.112, lot t969971) was returned with a complaint condition of a broken jaw on the straight end of the instrument.The complaint condition was confirmed after examination as an 11mm fragment broke off the jaw.A definitive root cause was unable to be determined; however the failure is consistent with the application of excessive force to the instrument (manufactured september 2011).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 material is corresponding to the specifications.The hardness was measured at the time of the manufacturing and was found to be good.No non-conformance reports were generated during production.The returned instrument was examined and the complaint condition was able to be confirmed.The material at the fracture site appears to be homogenous without signs of fatigue.The failure mode is consistent with a mechanical overload.The complaint is confirmed.Per the technique guides, 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.Relevant drawings for the returned instrument were reviewed, both current and from the time of manufacturing.The bender is 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.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A definitive root cause was unable to be determined; however the failure is consistent with the application of excessive force to the instrument.The calculated occurrence rate is acceptable under the system risk assessment.Additionally no design deficiencies were identified which would contribute to the complaint condition.Patient was involved but patient id is unknown 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: IN SITU BENDER-RIGHT
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• 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: 4740989
• MDR Text Key: 16183164
• Report Number: 9680938-2015-10039
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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: T969971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2011
• 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