MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL TRIAL SPACER 10MM X 28MM 9MM HEIGHT; TEMPLATE

Catalog Number 03.812.309

Device Problem Break (1069)

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

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not provided by reporter.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), 03.812.309 / 8705655, manufacturing date: 10.Dec.2013, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the knob at the top of the trial implant is broken and missing.This happened during surgery but there was no prolongation.There was no patient harm.They used another size of trial implant instead.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: (b)(6).A product investigation was completed: the trial implant is broken at the end of the coupling.The broken part is missing.The movable part of the instrument shows scratches on the surface.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Investigation results: several traces of mechanical damages found on the device, the microscopic view of the broken surface shows a homogenous surface what indicates material conformity.Product was produced in december 2013.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.Based on the investigation results and without all involved parts it is likely that the cause of the breakage is the result of a mechanical overload situation during use.Because of the damage, the complaint relevant dimensions cannot be checked.Finally we conclude that the cause of failure is not due to any manufacturing non-conformances.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 9MM 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: 5278013
• MDR Text Key: 33036587
• Report Number: 3003875359-2015-10518
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

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: 03.812.309
• Device Lot Number: 8705655
• Other Device ID Number: (01)07611819418998(10)8705655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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