MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE

Catalog Number 03.010.410

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(6).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.The 510k#: unknown; device is not distributed in the united states, but is similar to device marketed in the usa.Device history records review was conducted.The report indicates that the: 01.010.410/ l517235 manufacturing location: (b)(4).Manufacturing date: 16 august 2017.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Subject device has been received and a summary of the manufacturing investigation action was performed.The report indicates that the: 03.010.410.The handle presents strong traces of use on its surface.The instrument was received with the blade assembled in order to perform measurements; the blade was taken out from the instrument, which was easy if turned in the correct direction.A dhr check was performed for the components and final product; no issue or deviation, neither ncs were found which could lead to the complaint condition.As relevant for the complaint condition the thread m7, the hex 4.5 and the hex ø5.05, features which have contact with the blade, were measured.All features measured are according to the drawing,.And have passed the specifications through the gauges.During manufacturing process the features m7x1 lh and hex 4.5 were inspected and documented 100% and in final inspection by aql1 according to the inspection sheet.There is no functional test defined during manufacturing process for the instrument in question.However, this is covered by test with gage for the hex (2-09-08471 and 2-09-08472) and thread (4-19-10528 and 4-19-10529).The lots of the (b)(4) material (b)(4) and of the component (b)(4) are not tracked by lot number.Therefore, the check was performed based on fifo (first in/first out) by investigation of the (b)(4) material orders, which was closest to the start of the manufacturing order of the component however, the (b)(4) material used fulfilled the specifications.For evidence of used components and (b)(4) materials for 03.010.410 lot l517235 see sap screenshots.On the basis of the investigation the complaint is not confirmed, since the products if turned in the correct direction were easy to disassemble.No manufacturing issue could be found.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 on an event in (b)(6) as follows: it was reported that the pfna blade could not been detached from instrument while in patient.A surgical delay has been reported but the duration is not known.No information available about patient condition and outcome.This complaint involves 1 part this report is 1 of 1 for com-(b)(4).

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6858373
• MDR Text Key: 86843462
• Report Number: 9612488-2017-10469
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819349476
• UDI-Public: (01)07611819349476(10)L517235
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H10
• 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: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Device Lot Number: L517235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1