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U.S. Department of Health and Human Services


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Catalog Number 03.023.003
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device used for treatment, not diagnosis. 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. (b)(6). Subject device has been received and a device history records was conducted. The report indicates the: dhr review for part. : 03. 023. 003 / 2751708. Manufacturing location: (b)(4). Manufacturing date: 15 july 2011. No anomalies were detected during device history record review. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. An investigation summary was performed. The investigation of the complaint articles has shown that: as received condition received part: 1 x article 03. 023. 003 / awl f/pfna-ii / lot 2751708: the laser welded seam between the shaft and the handle was found broken. Furthermore we found strong hammering blows on the handle's surface. The cutting edges are blunt. Our microscopic observation shows remaining laser welds on both involved components showing that the weld joint was correct at the time of manufacturing. In particularly we want to bring up the heavy hammering marks on the handle, which are a clearly indication of an excessive force influence on the device. These repeatedly hammer blows have probably damaged the stability of the laser weld-seam which finally led into rupture of the welding joint. The actual surgical technique guide recommends how the awl should be used. There is no indication that a hammer or such a similar instrument can or must be used in combination with the awl. The article 03. 023. 003 with lot no 2751708 was manufactured in a quantity of 50 pieces on july 2011. All dimensions relevant for the function of the product were measured, and fulfil the specifications. The measurable dimensions of the awl were as far as possible checked and found to be in compliance with the technical drawings. We are not aware of any quality problems or failures caused by a faulty product on the article. Unfortunately we have no information in the complaint description about any event neither if a patient was involved in this case, which makes it impossible to determine how the device should had malfunctioned. Also we are not aware of any other complaint for this article- and lot number combination. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances. 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 product was returned because the handle is unsoldered. The handle came off the stem without breakage. During chu investigation was detected that the laser weldseam was found broken. This complaint involves 1 part. This report is 1 of 1 for: (b)(4).

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Type of DeviceAWL
Manufacturer (Section D)
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer (Section G)
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
MDR Report Key6066940
MDR Text Key58821977
Report Number9612488-2016-10437
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Catalogue Number03.023.003
Device LOT Number2751708
OTHER Device ID Number(01)07611819926622(10)2751708
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/06/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown