MAUDE Adverse Event Report: SYNTHES USA T-PAL SMALL TRIAL IMPLANT SIZ 10 NON DET

Catalog Number 03.812.310

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

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

Event Date 12/12/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6) that during the surgery on (b)(6) 2013 that when inserting and positioning the trial spacer in combination with the applicator outer shaft and applicator knob the trial implant rotated into position before being released from its constrained position on the applicator.The surgeon removed the trial implant and applicator and outside the patient was unable to secure the trail implant into the correct constrained position for insertion.The 11 mm small trial implant was selected and used instead and assembled with a different applicator and applicator knob.Upon disassembly and examination of the 10 mm trial spacer it was evident that the proximal tip of this instrument had broken off leading to the malfunction.The procedure was delayed about 5 minutes.The procedure was completed by using a different size trial implant and implant.It was reported that the product occurrence was not relevant to the health of patient.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument.Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of device history records was not performed the lot number was not provided.Placeholder.

• Brand Name: T-PAL SMALL TRIAL IMPLANT SIZ 10 NON DET
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: gbariel szasz ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3556279
• MDR Text Key: 4076198
• Report Number: 2520274-2013-07979
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 85