MAUDE Adverse Event Report: SYNTHES USA T-PAL TRIAL SPACER 12MM X 32MM; TEMPLATE

Catalog Number 03.812.511

Device Problem Separation Failure (2547)

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

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) reports an event in (b)(6) as follows: it was reported that during a spine surgery for degenerative disc disorder, on (b)(6) 2016, it was not possible to detach the trial implant from the applicator and applicator knob.The surgery was not prolonged.There was no patient harm and the surgery was completed successfully.A back-up applicator device was used to complete the surgery.Concomitant reported parts: 1x inner shaft (part 03.812.003 lot unknown).This is report 3 of 3 for com-(b)(4).This report is for one t-pal large trial implant.

Manufacturer Narrative

Additional narrative: previously reported concomitant part 03.812.003 is no longer considered as concomitant.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: T-PAL TRIAL SPACER 12MM X 32MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6222911
• MDR Text Key: 63868921
• Report Number: 2520274-2017-10022
• Device Sequence Number: 1
• Product Code: HWT
• 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,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INNER SHAFT (PART 03.812.003 LOT UNKNOWN) QTY 1