MAUDE Adverse Event Report: SYNTHES MONUMENT TRIAL SPACER HANDLE; FORCEPS

Catalog Number 389.151

Device Problems Material Fragmentation (1261); Metal Shedding Debris (1804)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.A review of the service history records has been requested and is currently pending completion.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

It was reported that during routine inspection of field equipment, two (2) synfix devices were noted to be compromised.It was reported that the threading on the tip of a secondary impactor (part 389.151) is sheared off and the inner cannula of a trial spacer holder (part 03.802.039) appears to be sheared off.There was no patient or procedural involvement.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A review of the service history records was attempted: service history review: part no: 389.151, serial/lot no: (b)(4), no service history review can be performed as this is a lot controlled item.The manufacture date of this item is 24-feb-2009.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.Service and repair evaluation were performed:the customer reported the inner cannula appeared to be sheared off.The repair technician reported the tip of the spindle assembly broke off.Tip broken is the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit on (b)(4) 2015.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

A product investigation was completed: the returned instruments were evaluated and in each instance the complaint was able to be confirmed as both instruments are missing the distal end of their threaded tips.A definitive root cause was unable to be determined however the failures are consistent with rough handling/cross threading.Per the technique guide, a trial spacer may be used as a template to facilitate the selection of the trial implant.A trial spacer handle is attached and controlled light hammering on the handle may be applied to advance the trial spacer into the disc space.The returned device (389.151, lot 75689 manufactured 24february2009) was received with the tip of the spindle assembly broken off and not returned.The associated drawings of the current release were reviewed.The drawings detail the appropriate dimensions, materials, and finishing process for a successful instrument.In addition, the drawings for the trials were reviewed.The drawings call out the appropriate thread and thread depth to fully seat the spindle assembly; additionally no changes or issues were identified with material and finishing processes for a successful trial spacer device design.This complaint failure could have been caused by improper technique (use of handle in loosened state, excessive impaction force, cross threading) leading to the fracture of the trial spacer handle spindle tip.A design change to the spindle subassembly was implemented through to address the breakage of the distal tip of the spindle prior to the manufacturing of this lot.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.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 that during a routine inspection of field equipment, two (2) synfix-lr devices were noted to be compromised.It was reported that the threading on the tip of the implant holder for synfix-lr is sheared off and the inner cannula of the trial spacer handle appears sheared off.There is no procedure or patient involvement.This is 2 of 2 reports for (b)(4).

• Brand Name: TRIAL SPACER HANDLE
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5027712
• MDR Text Key: 23947620
• Report Number: 1719045-2015-10534
• Device Sequence Number: 1
• Product Code: HTD
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 389.151
• Device Lot Number: 75689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2009
• 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