MAUDE Adverse Event Report: SYNTHES GMBH CONNECSCR F/DHS/DCS-WRENCH NO. 338.300

Catalog Number 338.310

Device Problems Break (1069); Component or Accessory Incompatibility (2897); Compatibility Problem (2960)

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

Event Date 05/30/2012

Event Type  malfunction  

Event Description

It was reported that the insertion handle is damaged and the connection screw broke during insertion.Also there were problems with the dhs screws being too large.The lcp dhs plate could not slide down over the screw.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Pma/510k#: device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records was performed and no complaint related issues were found.The additional evaluation revealed that high applied forces (very hard bone) caused these damages.The macroscopic examination has shown that the positioning pins of the complained dhs/dcs wrench are damaged (loosening direction/counterclockwise).In addition, the threaded tip of one connecting screw is broken off.These articles were manufactured according to the specifications.Placeholder.

• Brand Name: CONNECSCR F/DHS/DCS-WRENCH NO. 338.300
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4147778
• MDR Text Key: 4789683
• Report Number: 8030965-2014-01297
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2012

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: 338.310
• Device Lot Number: 3293515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2012
• Initial Date FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1