MAUDE Adverse Event Report: SYNTHES SELZACH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 03/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the intra-operative malfunction, the cement was not used during the procedure.Per facility, the complainant part was discarded and is not available for evaluation.(b)(6).A 510k number has not yet been assigned to this product.This ous product is similar to a device marketed in the us.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing site: (b)(4).Manufacturing date: september 30, 2015.No non-conformance reports 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 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 (b)(4) reports an event in (b)(6) as follows: it was reported that cement could not be mixed after the solvent was poured into the kit during a vertebroplasty procedure on (b)(6) 2016.The surgeon could only turn clockwise two (2) to three (3) times before the handle became stuck.The cement was discarded and a new kit was opened.The procedure was then completed successfully with only a five (5) minute delay.No information about patient condition was available.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Manufacturing investigation evaluation: the kit was received in an unpacked and used condition with the paddle blocked in the device.The article was forwarded to the legal manufacturer for evaluation.The returned kit, as well as the retention sample of the same lot number (5g53141), have been analyzed in the laboratory.The conducted investigation on the retention sample showed no deviations regarding handling.A functional test was also performed.The investigation on the complained kit did not identify an obvious root causes.Presumably, various cement impurities, alongside of the mixing axle, led to the jamming, which was likely caused by operating the mixer without adding the monomer.The instructions for use indicate that the mixing process and the movement of the mixing bar, along of the mixing axle, must not be carried out before the monomer has been added.A possible limitation can be avoided by a rapid start to the mixing process after adding the monomer.Since no manufacturing related issues were found, and the specific circumstances of user technique are unknown, the exact cause of failure could not be determined.However, this complaint condition is most likely a result of method of use.No manufacturing related issues were identified and/or confirmed.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

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VERTECEM V+ CEMENT KIT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5551860
• MDR Text Key: 41999370
• Report Number: 3000270450-2016-10087
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 5G53141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR