MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,SPINAL INTERLAMINAL

Device Problem Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the synapse system (snp) was used at c6-t3.After the sterilization, something like eraser shavings were attached to the bottom of the case of snp-1 which had been sterilized.Therefore, the surgeon needed to have the snp-1 in question sterilized again.No surgical delay was reported due to this event.This event was aware not after cleaning the case set in question but only after its sterilization.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product codes: mnh, mni.This report is for one unknown case of snp-1/unknown part/lot number.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: APPLIANCE,FIXATION,SPINAL INTERLAMINAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4242517
• MDR Text Key: 4992074
• Report Number: 2520274-2014-14631
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1