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

Catalog Number 388.720

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirmed that the material, components and final product met inspection records and certification.All 28 parts of the lot were checked for function at the final inspection.There were no non-conformances generated during production.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery on an unknown date, outside of the surgical field, part of the rod cutter broke off while cutting a 6mm rod.Fragments were generated but they were contained to the cutting area and did not enter the surgical field.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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 history records was conducted.The report indicates that the: part: 388.720 lot: t129611, manufacturing date: 17-dec-2015, review of the device history record showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the, material, components and final product met inspection records, certification.All 28 parts of the lot were checked for function at the final inspection on 15-dec-2015.No ncrs were generated during production.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 investigation has shown that a round shaped piece on both blades of the bolt cutter is broken off.The manufacturing documents were reviewed with no complaint related issues found.The lot in question was manufactured in december, 2015 with a total of 28 pieces made according to specifications.The intact part of the cutting blades show slight wear marks, which can be expected on a bolt cutter that was intensely use.Based on these findings, the cause of failure is not likely due to any manufacturing non-conformances.There was no information about the cutting procedure provided, which makes it impossible to determine the exact cause of this occurrence.However, the same kind of damage could be replicated during a performed test with a new bolt cutter.When cutting an extra-hard cobalt-chromium rod, the same malfunction occurred.With this type of rod, the new bolt cutter was damaged in the same manner after one cut.In this relation, it is important to note that this device is not suitable for cutting cobalt-chromium alloys.For cutting this kind of rod, the universal spine system rod cutting and bending device must be used.The device was manufactured according to specifications.Based on the dhr review, there were improvements made to the material in the meantime, but the cutter is still not able to cut an extra-hard cobalt-chromium rod 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.

Event Description

Concomitant device(s) reported: rod (part/lot: unknown / quantity: 1).

• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5739606
• MDR Text Key: 47896020
• Report Number: 9680938-2016-10087
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2016

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: 388.720
• Device Lot Number: T129611
• Other Device ID Number: (01)07611819710504(10)T129611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/21/2016; 07/08/2016; 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• 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