MAUDE Adverse Event Report: SYNTHES USA EXTRACTSCR F/PFNA BLADE; EXTRACTOR

Catalog Number 03.010.411

Device Problem Sticking (1597)

Patient Problem Sedation (2368)

Event Date 06/11/2015

Event Type  Injury  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the operation started as a normal implant remove.Nothing special was visual at the beginning.As the surgeon tried to remove the blade, we saw that the instrument toggled in the blade.As the surgeon started to hammer, the piece 525343 came out of the blade.Then the remove of the blade became much more demanding, as we needed the special extraction set for the blade and the operation was prolonged for more than 1 hour.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for unknown extractscr f/pfna blade/unknown lot number.Device is an instrument and is not implanted/explanted.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.

Manufacturer Narrative

(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Implant date reported on initial medwatch; device is an instrument and is not implanted/explanted.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.

• Brand Name: EXTRACTSCR F/PFNA BLADE
• Type of Device: EXTRACTOR
• 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: 4869795
• MDR Text Key: 6061922
• Report Number: 2520274-2015-14650
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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