MAUDE Adverse Event Report: SYNTHES BETTLACH COUPLING SCREW FOR EXTRACTION OF DHS BLADES; EXTRACTOR

Catalog Number 03.224.008

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).The upper and lower laser weld of the knob was found cracked, thus making the knob loose.The upper side of the shaft, where the knob was, is significantly damaged.In addition we found that the shaft is bent.The relevant dimensions were checked and no deviation was found.The manufacturing documents were reviewed and no complaint related issues were found.This lot also passed a torsion test at 5nm after laser welding as required.The lot was manufactured in may 2014.Based on the provided information it is not possible to determine the exact cause for this occurrence.It was found that the upper part of the shaft is significantly damaged.Based on the appearance of the damage it is most likely that a tool, such as forceps was used with high force to loosen the shaft after the knob came off.In addition, it was found that the shaft is bent and that the thread flanks are flattened at the forefront.All these damages are an indication that the instrument was possibly for any reason stuck in a blade and that high forces were used to remove the instrument, which led to the loosening of the knob.Dhr review - manufacturing location: (b)(4).Manufacturing date: 22th may 2014.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.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 eu reports an event in (b)(6) as follows: during surgery the knob at the proximal end of the coupling screw for extraction loosened.There was no patient impact due to the loosening.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A date of may 22, 2014 was erroneously reported in the initial mw; corrected date: dec 17, 2015 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.

Manufacturer Narrative

A date of may 22, 2014 was erroneously reported in the initial mw; the complaint was determined as being reportable upon the completion of the investigation on february 12, 2016.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: COUPLING SCREW FOR EXTRACTION OF DHS BLADES
• 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: 5434066
• MDR Text Key: 38130155
• Report Number: 9612488-2016-10085
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2015

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: 03.224.008
• Device Lot Number: 8933145
• Other Device ID Number: (01)10886982076991(10)8933145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/12/2016; 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2014
• 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