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

Catalog Number 388.72

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

It is unknown if there was patient involvement.Device is an instrument and is not implanted/explanted.No service history review can be performed as part number 388.72 with lot number(s) ai3da009 is a lot/batch controlled item.The lot/serial number cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.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 the jaws of the rod cutter shattered during use, the depth gauge tip broke, and the handle of the hammer broke.It is unknown if the three reported events occurred during the same surgery.The reported devices were set aside in the sterile processing room after sterilization with a note indicating the malfunction.The date of surgery, type of surgery, age of device, surgical delay, patient and procedure outcome remain unknown.Furthermore, the reporter could not confirm if any fragments were generated and if any fragments fell into or remain in the patient.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

The customer reported the jaws of the rod cutter shattered during use.The repair technician reported the cutting jaws were broken, and the device was an old revision so replacement jaws were not available.Cutting jaws broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.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

Dhr review for part #388.72, lot #a13da009.The device 388.72 is currently manufactured by synthes - (b)(4).Based on available records, it is most likely that the lot number for the returned device is a13da009 rather than ai3da009.Records related to either lot number were not available in (b)(4), as such no device history review was able to be performed.Device history documentation for lot a13da010 (released oct-1996) was located in (b)(4), therefore lot a13da009 was likely manufactured in oct-1996 and supplied by (b)(4).If new information becomes available, this action will be updated.The manufacturer investigation results are as follows.The complaint condition is confirmed.A visual inspection, complaint history review, drawing review, and service and repair (s&r) review was performed as part of this investigation.The returned part was determined to be suitable for their intended use when employed and maintained as recommended.The following drawings were reviewed during investigation: the complaint is confirmed.Upon visual inspection it can be seen that cutting jaw on the rod cutter is chipped,the balance of the device is in fair condition with signs of wear and tear.The rod cutter is an instrument utilized in the universal spinal system to cut rod to length during scoliosis surgery (per technique guide: j4437b).Drawings 388_72 revs a-g; 319_006, revisions f/l and 319_006_3 revisions a-e, and 03_010_056 revisions b/f and 03_010_058_4 revisions a/b.The drawings were found suitable to determine the intended device design, application and dimensional conformity.The instruments were found to have met the drawing specifications.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 MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6132746
• MDR Text Key: 61086099
• Report Number: 1719045-2016-10861
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2016

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: 388.72
• Device Lot Number: AI3DA009
• Other Device ID Number: (01)10705034773759(10)AI3DA009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2016; 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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