MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number 356.823

Device Problem Separation Failure (2547)

Patient Problem Sedation (2368)

Event Date 09/21/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the surgeon introduced the impactor with the proximal femoral nail antirotation (pfna) blade on it for placement however when he tried to remove it the hardware jammed.The surgeon removed the impactor with the drill sleeve and blade attached as one piece.This event resulted in a two hour delay in surgery.Patient outcome was reported to be ¿okay¿.The problem was resolved by using a plier wrench, striking forward and back until the blade released, the surgeon was then able to place another with the instrumental extraction this is report 1 of 3 for (b)(4).

Manufacturer Narrative

The part and lot number of the returned devices do not match the information reported.Device is an instrument and is not implanted/explanted.G5 510k#: device is not distributed in the united states, but is similar to device marketed in the usa the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: the visual inspection of the returned device performed as part of the manufacturing investigation reported the articles are blocked together.The blocked devices were removed together with the responsible product manager, the manager was able to separate the blade from the impactor.Functional testing showed that all devices are functional as required.Based on the provided complaint description the investigation was not able to determine the exact cause of this occurrence.The complaint condition is likely the result of either wrong direction of rotation of the left-hand threaded mechanism or the use of the key 356.823 caused the blocking of the devices.In this relation we would like to point out this key should be only used for the removal of the blade.The impactor 356.823 is an old version and should be replaced with the article 03.010.410 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4180970
• MDR Text Key: 5089991
• Report Number: 9612488-2014-10447
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2527522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 80