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

Catalog Number 03.224.008

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

Patient weight is not provided for reporting.Device is an instrument and is not implanted / explanted.(b)(6).(b)(4).Device history records review was completed for part# 03.224.008, lot# 2243209.Manufacturing location: (b)(4), manufacturing date: feb 20, 2007.No non conformance reports 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.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that the tip of a connecting screw for extraction of dynamic hip screw (dhs) blade broke off intraoperative on (b)(6) 2016.The dhs blade could not be removed and was left into patient's body.No prolongation of surgery was reported, no information about patient outcome was reported.Reported concomitant devices: dhs plate (quantity 1).Dhs locking screw (quantity 1).Cortical screw (quantity 1).This report is for one (1) coupling screw for extraction of dha blades.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device 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.

Event Description

Update 27 jan 2017: fragments were generated, but it's unknown, whether it was easy or difficult to remove them.There was no patient harm.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device.Article 03.224.008 lot 2243209.The investigation of the returned connecting screw has shown that the threaded tip is broken off as complained.The item shows some wear marks and scratches at the surface.An exact cause leading to the breakage was not able to be determined.It can be assumed that too much applied mechanical force caused this damage.One of the other reasons for the breakage may have been insufficient connection with the inserter.If the connection is not tight, the forces while hammering may cause the breakage of the threaded tip.The measurement of the relevant dimension has shown no deviation to the specification.Additionally, it was found that the connecting screw was manufactured in february 2007.As this instrument is already more than 10 years old, it cannot be ruled out that the damages were caused due to wear and tear over the years.To point out to the surgical technique it is important that the wrench and connecting screw must fit the dhs screw exactly.The connecting screw must be tightened securely.After removing the dhs plate, place the connecting screw through the cannulation of the extraction instrument and fix it to the dhs blade.The blade is then removed with soft backward slide hammering on the extraction instrument.Measurement outer diameter ø4.0 per drawing.Gage: (b)(4).Tolerance ø4.0 +0 / -0.1.Result: ø3.95 "pass".No product fault could be detected.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6280328
• MDR Text Key: 65847611
• Report Number: 9612488-2017-10038
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982076991
• UDI-Public: (01)10886982076991(10)2243209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.224.008
• Device Lot Number: 2243209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2007
• 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
• Treatment: ONE (1) UNKNOWN CORTICAL SCREW; ONE (1) UNKNOWN DHS LOCKING SCREW; ONE (1) UNKNOWN DHS PLATE
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR