MAUDE Adverse Event Report: SYNTHES TUTTLINGEN ROD CUTTER; CUTTER, WIRE

Catalog Number 388.72

Device Problem Dull, Blunt (2407)

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

Event Date 07/20/2015

Event Type  malfunction  

Event Description

It was reported that a surgeon had trouble cutting the external rod during an external fixation procedure.It was reported that the rod cutter seem to be chipped.There was no surgical delay or patient harm reported.The procedure completed successfully this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device service history record review has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Mfg date: additional manufacturing dates for this device include october 29, 2012.Manufacturing investigation evaluation: a little piece has sheared off at the cutting edges.A functional test, according to the associated drawing, with a dia.6mm titanium rod was carried out and the cutter was found to function properly and without any damages to the cutting edges.It appears that the cutters were used to cut cocr rods instead of titanium or steel rods.The hardness was not checked during the manufacturing evaluation as the device would require destructive testing.At this time, the root cause is being deemed ¿wrong usage.¿ no manufacturing issue was found during investigation.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

Additional narrative: 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.No service history review can be performed as this is a lot controlled item.The manufacture date of this item is 29-oct-2012.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.Device history records was conducted.The report indicates that the: manufacturing date: october 24th, 2012, 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.Service history review: lot no: t985174.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: ROD CUTTER
• Type of Device: CUTTER, WIRE
• 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: 4964811
• MDR Text Key: 6195886
• Report Number: 9680938-2015-10070
• Device Sequence Number: 1
• Product Code: HXZ
• 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
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.72
• Device Lot Number: T985174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2012
• 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