MAUDE Adverse Event Report: SYNTHES SELZACH TRAUMACEM V+ CEMENT KIT0; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Catalog Number 07.702.040S

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states.A device history record review was performed for the subject device lot number 5m53150.Manufacturing location:(b)(4).Supplier: external supplier (b)(4).Date of manufacture: 16.Mar.2016.Expiration date: 31.Dec.2018.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: this is the 2nd complaint to address the post-operative pain and resulting arthroscopic procedure.See (b)(4) to see original complaint 1.It was reported that it was reported that the actual cause for the leakage is unknown.To the extent the leakage could be an outcome of the banging in the attempt to remove the needle that was stuck in the blade, then the leakage may have been the cause of the pain in the hip joint of which the patient complained before an arthroscopic procedure was performed during which some of the leaked cement was removed.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the investigation of the trauma needle kit was performed in the linked complaint (b)(40 and has shown that according to our assessment, this is a handling error of the user.Substantiation: the only possibility to unlock the needle from the pnfa-system is to press the mechanical release.It is likely that the lock was not actuated.This would explain, as mentioned in the report, the needle could still be twisted, but could not be withdrawn from the system.According to the received information it cannot be excluded that the leakage could be an outcome of the banging in the attempt to remove the needle that was stuck in the blade, then the leakage may have been the cause of the pain.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.

Event Description

It was further reported that the patient is still experiencing some pain in her hip joint.

• Brand Name: TRAUMACEM V+ CEMENT KIT0
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6482709
• MDR Text Key: 72460965
• Report Number: 3000270450-2017-10129
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 07.702.040S
• Device Lot Number: 5M53150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR