MAUDE Adverse Event Report: SYNTHES SELZACH VERTECEM V+ SYRINGE KIT; CEMENT DISPENSER

Catalog Number 03.702.215S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(6).(b)(4).Device history records review was completed for part#: 03.702.215s, lot#: 6052681.Manufacturing location: (b)(4), manufacturing date: jul 26, 2016, expiry date: jun 01, 2021.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follow: it was reported that the cement of a vertecem v+ syringe kit was only enough for three injections and it ran out into patient¿s body.The date of event was not provided.No information about patient outcome and surgical prolongation.This report is for one (1) vertecem v+ syringe kit.This is report 1 of 1 for com-(b)(4).

• Brand Name: VERTECEM V+ SYRINGE KIT
• Type of Device: CEMENT DISPENSER
• 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: 6269722
• MDR Text Key: 65504852
• Report Number: 3000270450-2017-10019
• Device Sequence Number: 1
• Product Code: OAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 6052681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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
• Patient Outcome(s): Required Intervention