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

Catalog Number 03.812.310

Device Problem Mechanical Jam (2983)

Patient Problem Sedation (2368)

Event Date 05/21/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that two (2) devices used to insert the tpal were blocked in the close position and could not be removed during the surgical procedure.This resulted in the breakage of the implant at the proximal part.The other inserter was also blocked in the close position with the trial.There was a reported delay of sixty (60) minutes.This report is 4 of 7 for (b)(4).

Manufacturer Narrative

Additional patient information: patient height reported as (b)(6).Device is an instrument/template and is not implanted or explanted.Device is not distributed in the united states, but is similar to a device marketed in the us.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Without a lot number, the device history record review could not be requested.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.

Manufacturer Narrative

Manufacturing investigation evaluation: received one (1) article of t-pal small trial implant size 10 for manufacturing investigation.The part was received un-mounted, respectively not assembled with associated parts.On the shaft surface, there are some spots visible.During the manufacturing investigation, a functional test was performed.The article passed the functional test.Also, during a second test with the counterparts of this complaint a malfunction with the t-pal small trial implant was not observed.A malfunction of the recess has not been found.The cause for the malfunction is likely jamming, seizing on thread m16x1.5-lh, likely due to being used without proper lubrication.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.

Manufacturer Narrative

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.

Manufacturer Narrative

A product development investigation was performed ¿ two instruments received: a) assembled applicator (inner shaft, outer shaft and knob) containing broken part of peek implant b) assembled applicator (outer shaft and knob) containing trial implant small 10.The two received instruments were both jammed.With a force of around 3nm the thread could be released.Parts show normal wear and tear.The inner shaft (03.812.003) and the trial spacer (03.812.310) seem to be slightly bent.Assembly without inner shaft or trial implant does not produce resistance in thread.Only when the inner shaft or trial implant is inserted, the jamming occurs.The jamming happens just at the point where the security ring needs to be pushed down to release the retaining blocks.One of the two outer shafts shows corrosion.So does the inner shaft and the trial.This might have caused the jamming.Corrosion is addressed separately in the corrosion evaluation.The design of the parts is adequate.Parts shall be evaluated by production with a special focus on the thread of 03.812.001/004 and recess on 03.812.003/010.Dhr review ¿ manufacturing site: (b)(4).Manufacturing date: 17.Feb.2015.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition 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 10MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA 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: 4877787
• MDR Text Key: 19498833
• Report Number: 2520274-2015-14714
• 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,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.310
• Device Lot Number: 9271568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 56