MAUDE Adverse Event Report: SYNTHES USA WATER BATH STERILITY COVER; BATH, INCUBATORS, WATER/ALL

Catalog Number 530.514

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No reported patient or surgical involvement.Event date: the exact date of breakage is unknown; however, the issue was discovered upon delivery on (b)(6) 2016.Device product code ¿xxx¿ is being used to report unavailable code jtq, which corresponds with the reported common name.Partial udi number: (b)(4) lot unknown.Implant and explant dates: device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter hospital contact number: (b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the sterile tip of the device was broken during transport from the warehouse to the hospital.No patient or procedural involvement noted.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the evaluation has shown that the acrylic glass sterility cover for the water bath is cracked, without fragmentation, at its weakest point.The overall condition of the cover is very used with scratches all over and a dull surface.Based on this information, it can be concluded that this was an often and intensely used loan set device.Also, this cover was phased out in march, 2011.A review of shipment transactions has shown that this part was last shipped to (b)(4) in may, 2008.Based on this information, it can be assumed that this device is at least eight (8) years old.Based on these findings, a manufacturing related issue can be excluded.Based on the complaint description, it can be assumed that inappropriate handling during transportation led to the damage on the cover.No product related issues were detected.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.

• Brand Name: WATER BATH STERILITY COVER
• Type of Device: BATH, INCUBATORS, WATER/ALL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5707162
• MDR Text Key: 48045461
• Report Number: 2520274-2016-13071
• Device Sequence Number: 1
• Product Code: JTQ
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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