MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL IMPLANT SPACER 12MM X 32MM 8MM HEIGHT; TEMPLATE

Catalog Number 03.812.508

Device Problem Material Fragmentation (1261)

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

Event Date 02/28/2014

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: the complaint received states on (b)(6) 2014; the ball at the tip of the trail implant has broken off.This was discovered during a procedure when the customer tried to attach the trial implant to the handle.It was reported that during a previous procedure the ball broke off and the staff was not aware of the issue.There was a readily available device present.They had another trial implant and handle they could use.There was no patient harm reported.Device will be returned for investigation.No additional information about the event is available at this time.This is report number 1 of 1 for com(b)(4).

Manufacturer Narrative

(b)(6).A device history review was conducted.The report indicates that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.Subject device has been received and is currently in the evaluation process.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 manufacturing evaluation was completed: the present transforaminal posterior atraumatic lumber trial implant was analyzed for conformance to print specifications as well as the device history record was researched; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question.Our analysis of the material shows that the broken surface is homogenous and confirms therefore absolutely to our specifications.Based on these findings it is likely that the cause of failure is not due to any manufacturing non-conformances.Based on the provided information we are not able to determine the exact cause.It is likely that strong hammering during the surgery has finally led to the breakage of the transforaminal posterior atraumatic lumber trial implant - shaft tip.No product fault could be detected.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 IMPLANT SPACER 12MM X 32MM 8MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3715544
• MDR Text Key: 4249564
• Report Number: 3003875359-2014-10053
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

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: 03.812.508
• Device Lot Number: 7517647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 03/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2011
• 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