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

Catalog Number 03.812.512

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

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

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.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 during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 synthes (b)(4) reported events in (b)(6) as follows: it was reported that the tip of the trial implant broke off during a t-pal spinal surgery on (b)(6) 2016.The implant was assembled inside the applicator.It was noticed that there was something wrong when the surgeon tried to insert the next size trial into the applicator and it would not hold.They took the applicator and the knob apart and found the tip of the trial implant inside the knob.All broken pieces were removed from the patient.There was no patient harm as they used the next sized trial implant instead.There was no reported surgical delay due to the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (t-pal trial spacer 12mm x 32mm 12mm height, part number 03.812.512, lot number 9273166).The subject device was returned with the complaint that the device (trial spacer) broke during surgery.The tip of the complaint trial spacer was found in the applicator upon insertion of the next trial spacer.There were no fragments retained in the patient.The subject device was received with the knob at the end of the implant broken off as complained.The hardness and the undercut diameter of the subject device were measured and found to be within specification.As previously reported, the review of the device history records confirmed that there were no issues during the manufacture of the subject device that would have contributed to the complaint condition.Though a definitive root cause could not be determined, it is likely that breakage was caused by high mechanical force applied during use.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 12MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5390614
• MDR Text Key: 36819980
• Report Number: 3003875359-2016-10047
• Device Sequence Number: 1
• Product Code: HWT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.512
• Device Lot Number: 9273166
• Other Device ID Number: (01)07611819420731(10)9273166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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