MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM 11MM HEIGHT; TEMPLATE

Catalog Number 03.812.311

Device Problem Break (1069)

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

Event Date 03/25/2014

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that when it was attempted to connect the trial implant into the applicator shaft and knob, the little knob on top of the trial implant broke off and was stuck into the applicator knob.The complaint received states that both instruments didn't work anymore.This happened outside of the patient and there was no delay in time.This is report number 1 of 1 for com-(b)(4).

Manufacturer Narrative

This device is an instrument and is not implanted or explanted.A device history review was conducted.The report indicates that were no ncrs were generated during production.There were no issues during the manufacture of the product that would contribute to this complaint condition.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

Additional narrative: a manufacturing evaluation was completed: the coupling tip of the trial had broken off.The broken off part is jammed in the applicator knob.Our investigation of the complained trial implant, article 03.812.311, and the applicator knob, 03.812.004, has shown that the coupling tip of the trial had broken off.The broken off part is jammed in the applicator knob.The applicator knob shows hammering marks on the top and the release function is not working.The fracture surface on the trial is homogenous what indicates material conformity.The manufacturing review of both instruments shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.It is likely that strong hammering on the applicator knob during the surgery led to the breakage of the trial tip.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.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 SPACER 10MM X 28MM 11MM 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: 3759270
• MDR Text Key: 4463912
• Report Number: 3003875359-2014-10074
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

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: 03.812.311
• Device Lot Number: 7542757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• 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