MAUDE Adverse Event Report: SYNTHES BETTLACH; EXTRACTOR

Catalog Number 03.010.411

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is not distributed in the united states, but is similar to device marketed in the usa device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4), manufacturing date: 22 april 2015, 03.010.411 / 9425345.No ncrs 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that after surgery they tried to remove the blade from the extraction instrument but could not get it off, finally they tried it with force and the instrument broke.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).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.

• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5265555
• MDR Text Key: 32659440
• Report Number: 9612488-2015-10605
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: 9425345
• Other Device ID Number: (01) 07611819349483(10)9425345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1