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 Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: during insertion of the trial implant the implant turned prior to release of the top knob, also the top part of the trial implant broke off.This part stayed lodged in the applicator knob and could not be removed, thus rendering the instrument unusable.Closer inspection of the outer shaft showed that the outer end blocking the rotation is deformed.No prolongation of surgery was reported as there is also a second implant inserter on the set, so no harm to the patient was done.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Date of event: unknown.Device is an instrument and is not implanted/explanted.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.The lot number provided could not be verified; therefore, further investigation cannot be performed.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

The investigation could not be completed; no conclusion could be drawn, as a review of the device history records was performed and no complaint related issues were found.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

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 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: patient identifying information is not available for reporting.(b)(6).Product investigation evaluation: the investigation has shown that the coupling part of the t-pal trial implant (03.812.311) is broken off as complained.The broken off part is still jammed in the applicator knob (03.812.004).In addition, the outer shaft (03.812.001) presents some deformations at the interface between the shaft and the trial implant.The review of the production history revealed that the returned articles were manufactured according to the specifications (03.812.311 in feb 2013, 03.812.004 and 03.812.001 in march 2013).No manufacturing related issues that would have contributed to this complaint condition were found.Although, the relevant dimension of the coupling part cannot be measured due to its broken off condition.Based on these findings, it is likely that, during the pivoting insertion of the trial implant, the applicator knob was not turned counterclockwise enough (as described on page 17 in the surgical technique guide).This likely led to a collision between the trial implant and the applicator outer shaft, causing the deformation at the interface as well as the jamming in the knob and finally resulted in the breakage of the coupling part of the trial implant.Conclusion: the type and extent of damage incurred indicate that this complaint was caused by wrong handling.No indication for material or design related issue.Device 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 PA 19380 CH4; SZ 19380 CH46
• 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: 4316919
• MDR Text Key: 5252311
• Report Number: 2520274-2014-15233
• 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,Followup,Followup
• Report Date: 11/11/2014

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: 8128968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2015; 02/20/2015; 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2013
• 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